public health draft guidance - NICE

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DRAFT Cardiovascular disease consultation draft Page 1 of 96 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE PUBLIC HEALTH DRAFT GUIDANCE Issue date: March 2010 Prevention of cardiovascular disease at population level NICE public health guidance x Introduction The Department of Health (DH) asked the National Institute for Health and Clinical Excellence (NICE) to produce public health guidance on the prevention of cardiovascular disease (CVD) at population level. (CVD includes coronary heart disease [CHD], heart failure, stroke and peripheral arterial disease.) The guidance is for government, industry, the NHS and all those whose action influences the populations cardiovascular health. This includes professionals, commissioners and managers working in local authorities, education and the wider public, private, voluntary and community sectors. It may also be of interest to members of the public. The guidance complements, but does not replace, NICE guidance on smoking cessation, physical activity, obesity and maternal and child nutrition (for further details, see section 7). It will also complement NICE guidance on alcohol which is currently under development. The Programme Development Group (PDG) has considered both the reviews of the evidence and the economic analysis.

Transcript of public health draft guidance - NICE

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NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

PUBLIC HEALTH DRAFT GUIDANCE

Issue date: March 2010

Prevention of cardiovascular disease at population

level

NICE public health guidance x

Introduction

The Department of Health (DH) asked the National Institute for Health and

Clinical Excellence (NICE) to produce public health guidance on the

prevention of cardiovascular disease (CVD) at population level. (CVD includes

coronary heart disease [CHD], heart failure, stroke and peripheral arterial

disease.)

The guidance is for government, industry, the NHS and all those whose action

influences the population‟s cardiovascular health. This includes professionals,

commissioners and managers working in local authorities, education and the

wider public, private, voluntary and community sectors. It may also be of

interest to members of the public.

The guidance complements, but does not replace, NICE guidance on smoking

cessation, physical activity, obesity and maternal and child nutrition (for further

details, see section 7). It will also complement NICE guidance on alcohol

which is currently under development.

The Programme Development Group (PDG) has considered both the reviews

of the evidence and the economic analysis.

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This document sets out the Group's preliminary recommendations. It does not

include all sections that will appear in the final guidance. NICE is now inviting

comments from stakeholders (listed on our website at: www.nice.org.uk).

Note that this document does not constitute NICE's formal guidance on

prevention of cardiovascular disease at the population level. The

recommendations made in section 4 are provisional and may change

after consultation with stakeholders and fieldwork.

The stages NICE will follow after consultation (including fieldwork) are

summarised below.

The Group will meet again to consider the comments, reports and any

additional evidence that has been submitted.

After that meeting, the Group will produce a second draft of the guidance.

The draft guidance will be signed off by the NICE Guidance Executive.

For further details, see „The NICE public health guidance development

process 2009: An overview for stakeholders including public health

practitioners, policy makers and the public (second edition)‟ (this document is

available at www.nice.org.uk/phprocess).

The key dates are:

Closing date for comments: 16 November 2009.

Next Group meeting: 19 November 2009.

Members of the PDG are listed in appendix A and supporting documents used

to prepare this document are listed in appendix E.

This guidance was developed using the NICE public health programme

process.

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Contents

1 Key priorities .............................................................................................. 4

2 Public health need and practice ................................................................ 4

3 Considerations .......................................................................................... 9

4 Recommendations .................................................................................. 22

5 Implementation ........................................................................................ 39

6 Recommendations for research .............................................................. 40

7 Updating the recommendations ............................................................... 40

8 Related NICE guidance ........................................................................... 40

9 References .............................................................................................. 42

Appendix A Membership of the Programme Development Group (PDG), the

NICE project team and external contractors .................................................. 48

Appendix B Summary of the methods used to develop this guidance ........... 54

Appendix C The evidence .............................................................................. 62

Appendix D Gaps in the evidence .................................................................. 93

Appendix D Gaps in the evidence .................................................................. 93

Appendix E: supporting documents ............................................................... 94

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1 Key priorities

This section will be completed in the final document.

2 Public health need and practice

Cardiovascular disease (CVD) is generally due to reduced blood flow to the

heart, brain or body caused by atheroma or thrombosis. It is increasingly

common after the age of 60, but rare below the age of 30. Plaques (plates) of

fatty atheroma build up in different arteries during adult life. These can

eventually cause narrowing of the arteries, or trigger a local thrombosis (blood

clot) which completely blocks the blood flow. The main types of CVD are

coronary heart disease (CHD), stroke or peripheral arterial disease (PVD)

(British Heart Foundation 2009).

A large number of preventable illnesses and deaths are associated with CVD.

Globally, it is the leading cause of death (World Health Organization 2007).

In the UK, it led to over 190,000 deaths (accounting for 40% of all deaths in

the UK) in 2007. Specifically, there were 91,458 deaths from coronary heart

disease (CHD) and 53,186 from stroke (Heartstats 2009). In 2006, 30% of

premature deaths among men (that is, among men aged under 75) and 22%

of deaths among women aged under 75 were caused by CVD, accounting for

just over 53,000 premature deaths in that year.

More than 4 million people in the UK are currently affected by the condition

and it costs the UK approximately £30 billion annually (Luengo-Fernandez et

al. 2006).

Despite recent improvements, UK death rates from CVD are relatively high

compared with other developed countries (only Ireland and Finland have

higher rates). There is also considerable variation within the UK itself –

geographically, ethnically and socially. For instance, premature death rates

from CVD are up to six times higher among lower socioeconomic groups than

among more affluent groups (O‟Flaherty et al. 2009). In addition, death rates

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from CVD are approximately 50% higher than average among South Asian

groups (Allender et al. 2007). The reduction in CVD-related risks among

younger men (and perhaps women) over previous years seems to have

stalled from around 2003. This is the case in a number of countries including

Scotland (O‟Flaherty et al. 2009), Australia (Wilson 1995) and the United

States (Ford and Capewell 2007).

The higher incidence of CVD is a major reason why people living in areas with

the worst health and deprivation indicators (the Spearhead areas) have a

lower life expectancy compared with those living elsewhere in England. For

males, it accounts for 35% of this gap in life expectancy (70% of this is due to

CHD). Among females, it accounts for 30% of the gap (63% of this is due to

CHD) (DH 2008a).

In 2009, the Cardio and Vascular Coalition published „Destination 2020‟, the

voluntary sector‟s plan for cardiac and vascular health (Cardio and Vascular

Coalition 2009).

Risk factors

CVD is influenced by a variety of „upstream‟ factors (such as food production,

access to a safe environment that encourages physical activity and access to

education) and 'downstream' behavioural issues (such as diet and smoking)

In more than 90% of cases, the risk of a first heart attack is related to nine

potentially modifiable risk factors (Yusuf et al. 2004):

smoking/tobacco use

poor diet

insufficient physical activity

high blood pressure

obesity/overweight

diabetes

psychosocial stress (linked to people‟s ability to influence the potentially

stressful environments in which they live)

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alcohol consumption

high blood cholesterol.

Actions which impact on the whole population most effectively reduce these

risk factors (Kelly et al. 2009). Other factors, such as maternal nutrition and

air pollution may also be linked to the disease (Allender et al. 2007).

Reducing the risks by, for example, reducing cholesterol or blood pressure

levels, quitting tobacco or improving dietary intake can rapidly reduce the

likelihood of developing CVD. For example, it is estimated that around 70,000

premature deaths a year in the UK (the majority caused by CVD, with some

deaths from cancers) could be avoided if people‟s diets matched nutritional

guidelines (Strategy Unit 2008).

Tackling the risk factors

Some population-based prevention programmes have been accompanied by

a substantial reduction in the rate of CVD deaths. However, the degree to

which these are attributable to the programme is contested. This is due to a

number of reasons including:

It is difficult to design studies which evaluate entire cities, regions or

countries or are of sufficient duration.

Control sites can become „contaminated‟ (that is, if the intervention affects

people living in the control area).

There may be unreasonable expectations about the speed of change.

Behaviour change is often erratic or slow.

Failure to address „upstream‟ influences such as policy or manufacturing

and commercial practices.

The crucial importance of using policy to modify population-wide CVD risk

factors has been recognised on an international, European and national level.

For example, the World Health Organization‟s (WHO) first global treaty on

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health, the „Framework convention on tobacco control‟ (2003) undertook to

enact key tobacco control measures, such as tobacco tax increases,

smokefree public places, and tobacco advertising controls. Parties to the

treaty included the UK.

In 2004, WHO member states also agreed to a non-binding global strategy on

diet, physical activity and health. In addition, since 1993 the European Union

(EU) has legislated on issues such as advertising and the labelling of

consumer products like food and tobacco.

Government policy

Government policy in many areas influences CVD, and policy documents from

many departments and agencies are important. The „Choosing health‟ white

paper (DH 2004) set priorities for action on nutrition, physical activity, obesity

and tobacco control. It was supported by delivery plans on food, physical

activity and tobacco control, including the provision of NHS Stop Smoking

Services.

Since that time, a wide variety of policy documents have been published to

help prevent CVD, including:

„Commissioning framework for health and well-being‟ (DH 2007a)

„Delivering choosing health: making healthier choices easier‟ (DH 2005a)

„Health challenge England – next steps for choosing health‟ (DH 2006a)

„Healthy weight, healthy lives: a cross-government strategy for England‟

(DH 2008b)

„National stroke strategy‟ (DH 2007b)

„Our health, our care, our say‟ (DH 2006b)

„Putting prevention first – vascular checks: risk assessment and

management‟ (DH 2008c)

„Tackling health inequalities – a programme for action‟ (DH 2003)

„Tackling health inequalities: what works‟ (DH 2005b)

„Tackling health inequalities: 2007 status report on the programme for

action‟ (DH 2008a)

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„The NHS in England: the operating framework for 2006/7‟ (DH 2006c)

„The NHS in England: the operating framework for 2008/9‟ (DH 2007c)

„Wanless report: securing good health for the whole population‟ (Wanless

2004).

In 2008, 10 years after publication of the first tobacco white paper, „Smoking

kills‟, the Department of Health held a consultation on the future of tobacco

control. A new tobacco white paper is expected later in 2009.

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3 Considerations

The Programme Development Group (PDG) took account of a number of

factors and issues when developing the recommendations.

Introduction

3.1 Evidence was presented on how to prevent or reduce the

combination of risk factors that can cause cardiovascular disease

(CVD). The PDG felt it was also important to consider the key risk

factors separately and so expert testimony was invited on specific

topics and relevant existing NICE guidance was summarised.

The reviews, together with the expert testimonies, are listed in

appendix A.

3.2 CVD risk factors can be reduced in a number of ways. For instance,

people can be directly encouraged to change their behaviours by

providing them with information about health risks, advice to be more

active or by prescribing a treatment. NHS and other organisations

can be changed by altering the way prevention or health care

services are delivered. The environment can also be changed by

altering the physical layout of towns and cities. In addition, laws,

taxation and national policy can be used to help change the risks

faced by an entire population.

3.3 Epidemiological studies indicate that approximately 45–75% of the

recent fall in CVD deaths in industrialised countries was as a result of

prevention activities. Around 25–45% of the decrease was due to

treatment.

3.4 The PDG noted that CVD death rates are no longer falling among

young people in the UK (for instance, among those aged 35–54 in the

most socially deprived groups in Scotland), the USA and Australia.

This reflects a combination of adverse risk factors including smoking,

a poor diet and deprivation (O‟Flaherty et al. 2009).

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3.5 The government‟s health checks programme („Putting prevention

first‟) focuses on identifying, measuring and addressing CVD risk

factors (such as high blood pressure and high cholesterol) among

people aged between 40 and 74. The NICE guidance complements

the health checks programme by focusing on reducing the risk factors

for an entire population. This will benefit the NHS, local authorities

and industry, as well as individuals, by substantially reducing the

number of people who need statin or anti-hypertensive medication. It

will also enable services to focus on those who need treatment.

3.6 The falls in blood pressure and cholesterol levels seen in many

Western populations are mainly attributable to changes in behaviour

and the wider determinants of health, rather than to medication Thus,

preventive services alone are not likely to be sufficient unless

supported by national policies and systems (Capewell and O‟Flaherty

2008).

3.7 National policy has an important role to play in changing the risk

factors faced by a population. However, developing and

implementing such policy is itself a highly complex process: the PDG

acknowledged that the policy process is not linear and rarely moves

from design to implementation. In addition, it acknowledged that

evidence alone is rarely sufficient to bring about policy change.

The way research evidence influences the policy process and gets

translated into action can be explained by models such as Kingdon‟s

(1995) `policy windows‟ model. It is claimed that „windows‟ open (and

close) by the coupling (or de-coupling) of three „streams‟: problems,

policies and politics.

„Problem window‟: Only problems seen as amenable to policy

solutions might be selected, many will remain unaddressed.

Problems may be brought to the fore by research evidence,

critical incidents, performance data or feedback.

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„Policy window‟: Many strategies or initiatives may be advanced

by civil servants, politicians and interest groups. To be enacted,

policy must be technically feasible, congruent with dominant

values and anticipate future constraints.

„Politics window‟: When lobbying, negotiation, bargaining and

coalition-building is in favour of the policy.

The alignment of the three „windows‟ may occur by chance, by

natural cycles (for example, political or organisational) and as a result

of action by `policy entrepreneurs‟. The latter use their status,

reputation and influence to advance policies they favour. The

`windows‟ model can be applied at national and local level (Exworthy

et al. 2002).

3.8 The PDG noted that interagency collaboration (nationally and locally)

is needed to ensure policy is successfully implemented. It also noted

the difficulties of both interagency and cross-government working

(Strategy Unit 2008; Wanless 2004). Some of the issues addressed

in this guidance have been debated by government. However,

implementation of the recommendations will need to be considered

further.

Population versus individual approaches

3.9 In the past in the UK, interventions focused on individuals have

tended to dominate CVD prevention activities. However, the largest

overall benefit could be achieved by making changes (albeit small

ones) within the population as whole. As indicated by the Rose

hypothesis, a small reduction in risk among a large number of people

may prevent many more cases, rather than treating a small number

at higher risk. A whole-population approach explicitly focuses on

changing everyone‟s exposure to risk (Rose 2008). This may be best

achieved through „upstream‟ interventions: fiscal measures (including

taxation), national or regional policy and legislation (including, for

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example, legislation on smokefree public places or the way food is

produced). Social and economic action can also result in a change in

CVD risk (in such cases, the health outcomes are side effects – albeit

desirable). Voluntary action may be effective. Sometimes, however, it

may need to be supported by mandatory measures, for instance,

when the pace of change is insufficient.

Data from „natural experiments‟ in a whole population (where there

were no randomised controlled trials to assess the results) provide

compelling evidence. One example is the reduction in the

consumption of animal fats in Eastern Europe, following the break-up

of the Soviet Union (Zatonski and Willett 2005). Another example is

the introduction of legislation in Mauritius to make it mandatory to use

polyunsaturated oils as a substitute for highly saturated cooking oils.

In such cases, there has been a remarkably rapid reduction in CVD

mortality among the populations (Dowse et al. 1995). Conversely,

rapid rises in CVD mortality have been seen in China and elsewhere,

principally due to the adoption of a Western diet rich in saturated fats

(Critchley et al. 2004).

3.10 Measures to encourage commercial markets to be health promoting

could be highly cost effective (Abelson 2003; Catford 2009; Trust for

America‟s Health 2008; Wanless 2004). Such measures might

include: improving the contents of products (re-formulation); controls

on the marketing of energy dense, nutrient poor, high fat, salt and

sugar processed foods; and package labelling.

3.11 Advertising and promotion activities have an important influence on

consumption patterns. The PDG felt that children are particularly

vulnerable and need to be protected from commercial pressures. The

„Sydney principles‟ (from Sydney, Australia) provide an example of

the type of issues that should be addressed. These state that any

action to reduce marketing to children should: support the rights of

children; afford substantial protection to children; be statutory in

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nature; take a wide definition of commercial promotion; guarantee

commercial-free childhood settings; include cross-border media; and

be evaluated, monitored and enforced. Closer to home, the

Ofcom/Food Standards Agency TV advertising restrictions on foods

high in salt, fat and sugar to children are an example of UK action to

put such principles into practice.

3.12 Interventions which rely on people deciding to change their behaviour

are likely to vary in effectiveness. For example, people who are

disadvantaged might find it more difficult to change than affluent

people. As a result, some interventions that focus on changing

behaviour may inadvertently increase health inequalities. To

overcome this, the recommendations do not, in the main, rely on

individual choice but, rather, aim to make the healthy choice the easy

choice. Hence, the emphasis is on changing policies, systems,

regulations and other similar „upstream‟ factors. This approach is

likely to reduce, rather than increase, health inequalities and is

congruent with NICE‟s guidance on behaviour change (see section

8).

Private, regional and community action

3.13 Public, private, voluntary and community sector organisations all

have a role to play in preventing CVD at EU, national, regional, sub-

regional (for instance county-wide) and local level. Those preparing,

manufacturing and selling food have a particularly important role.

Such organisations must consider their commercial interests.

However, the PDG considers it reasonable to expect them to work

with others to help prevent CVD. It takes this view in light of the

diseases and deaths caused by CVD (and the consequent costs to

the exchequer and society). The PDG noted Brownwell and Warner‟s

comments (2009) that some responsible commercial organisations

are already taking positive action. However, these authors also point

out that other parts of the food industry have sometimes defended

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their market by adopting similar strategies to those used by the

tobacco industry in the 1950s and 1960s. They state: „Certainly, there

is an opportunity if the industry chooses to seize it – an opportunity to

talk about the moral high ground and to occupy it'

3.14 The success of legislation banning tobacco advertising and smoking

in public places has demonstrated the effectiveness of national

government action to improve the public‟s health. In terms of CVD

prevention, government offices and strategic health authorities could

make an important contribution at regional level. For example, they

could negotiate local area agreements (LAAs) that include „stretched‟

targets related to CVD. They could also ensure that the DH‟s world

class commissioning strategies for health and social care adequately

address CVD prevention at both a population and individual level.

There is also scope for effective action by public sector bodies at a

sub-regional level. This was the case in Merseyside where, in the run

up to the national workplace ban on smoking, local smoking

restrictions had been considered in the absence of national

legislation.

3.15 Local authorities and primary care trusts, working with the private and

voluntary sector in local strategic partnerships, have demonstrated

their commitment to CVD prevention. For example, they have

established health and wellbeing partnerships. In addition, 5 of the 15

most popular improvement targets included in local area agreements

for England relate directly or indirectly to CVD prevention.

3.16 The role of voluntary and community sector groups and organisations

in CVD prevention is important. Nationally, the campaigning activities

of charities such as the British Heart Foundation, the National Heart

Forum and others focused on chronic diseases are particularly

influential. Local advocacy is also important and may be supported by

the voluntary sector. For example, it could have an impact on

planning applications for fast-food outlets.

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3.17 Addressing the needs of deprived groups involves working beyond

geographical boundaries with community groups. The leaders of

some communities may be able to deliver CVD prevention

programmes effectively. However, it should not be assumed that all

community leaders will be able or willing to participate – or that it

would be appropriate.

3.18 The PDG recognised that smoking cessation and other services that

aim to help people who are trying to change their behaviour have an

important role to play in preventing CVD. Many of these services or

approaches have been the focus of earlier NICE guidance (see

section 7).

Single risk factors

3.19 Key CVD risk factors are: smoking, a poor diet, obesity, lack of

physical activity and high alcohol consumption.

3.20 The PDG noted that approximately 100,000 people die from smoking-

related diseases in the UK every year (it accounts for 29% of deaths

from cancer, 13% of cardiovascular deaths and 30% of deaths from

respiratory disease) (Action on Smoking and Health 2008). It also

acknowledged that smoking accounts for over half the

disproportionate burden of illnesses experienced by deprived groups

and strongly endorsed the national tobacco control measures set out

in „Beyond smoking kills‟ (Action on Smoking and Health 2008).

Approaches to helping people to quit smoking, or to stop using other

forms of tobacco, are covered by recommendations made in NICE

guidance on: „Smoking cessation services‟ (NICE public health

guidance 10); „Brief interventions and referral for smoking cessation‟

(NICE public health guidance 1); and „Workplace interventions to

promote smoking cessation‟ (NICE public health guidance 5). As a

result, tobacco issues are not covered in this guidance.

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3.21 The PDG noted that nicotine replacement therapy (NRT) can help to

reduce CVD among people who are addicted to nicotine. The PDG

fully endorses the Tobacco Advisory Group‟s recommendations on

the regulation and marketing of NRT (Royal College of Physicians

2007). The report advocates making NRT more acceptable and

accessible to people who smoke and who find it impossible to quit.

3.22 In response to feedback from stakeholders, the PDG felt it was

important to also consider single risk factors and to make

recommendations on the use of salt and saturated, unsaturated and

trans fats in food. Policies to promote physical activity were also

considered.

3.23 Much of the observational evidence that links diet to CVD is based on

individual nutrients. However, the PDG recognised that their impact

should be considered in the context of the whole diet. A „healthier‟

diet based on fruit, vegetables, wholegrain foods, fish and poultry is

associated with a reduction in CVD risk factors (Fung et al. 2001;

Lopez-Garcia et al. 2004) and lower CVD mortality (Heidemann et al.

2008; Osler et al. 2001). Interventions promoting this type of

„healthier‟ diet have also been shown to be highly effective in

reducing blood pressure (Appel et al. 1997) and the risk of

cardiovascular disease (de Lorgeril et al. 1999). While a number of

the recommendations relate to single nutrients, the PDG recognises

that a „healthier‟ diet is likely to comprise a balance of nutrients and a

reduction in the intake of harmful elements. In a typical Western diet,

the latter include saturated fat and salt (Hu 2008).

3.24 The PDG agreed with the 2009 WHO review of industrial trans fatty

acids (TFAs) that they are unnecessary and „toxic‟ and should be

eliminated. Assuming a linear dose response, a reduction in energy

from TFAs to less than 1% of food energy might save between 4500

and nearly 7000 lives. It would also help reduce health inequalities. It

noted that bans have been successfully implemented in Denmark

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and New York City. The review states: because TFAs produced by

partial hydrogenation are not normally present naturally in foods and

have no known health benefits, the group considered them as

industrial additives‟. It recommends that, food services, restaurants,

and food and cooking fat manufacturers should avoid their use as

well (Uauy et al. 2009).

The WHO review noted that people who use partially hydrogenated

vegetable oils (PHVO) for cooking or consume a high proportion of

industrially processed or restaurant food, would have mean trans

fatty acids intakes considerably higher than the national average.

The review noted that ‟…replacing TFAs with vegetable oils high in

polyunsaturated fatty acids (PUFA) and monounsaturated fatty acids

(MUFA) is the preferred option for health benefits… eliminating use of

TFA-containing PHVO [partially hydrogenated vegetable oils] should

be considered as hazard removal, in line with risk management

models used to address many other food safety issues.‟

3.25 The PDG discussed the benefits of substituting low-fat for high-fat

products. Evidence suggests that reducing saturated fat intake from

14% to 6% of energy intake (as in Japan) might prevent around

30,000 CVD deaths annually. High levels of sugar may be used to

replace the fat, thereby losing some of the benefit in terms of calorie

reduction. It was also concerned total fat intake would not be reduced

but rather moved from one product to another.

3.26 Salt intake is a major determinant of CVD in the UK, mainly due to its

effect on blood pressure. Between 10 and 30% of a person‟s salt

intake comes from adding it to food and using it in cooking, 70–90%

is added to food during the manufacturing process. Reducing the

population‟s salt intake will therefore involve encouraging the food

processing industry to reduce the salt in processed foods – as well as

changing people‟s use of „discretionary‟ salt. The PDG believes the

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former can only be achieved by using a combination of voluntary and

regulatory action.

The PDG also noted that the UK population‟s daily salt intake has

fallen by 0.9g in the last 5 years (a reduction of around 2% per year).

This means people are consuming an average of 8.6g of salt per day.

The PDG noted that this reduction has come about as a result of

public awareness campaigns and a voluntary code of practice for

industry, led by the Food Standards Agency.

3.27 Evidence shows that large reductions in the salt content of foods are

feasible; a 10% reduction in items like bread and soups is not

detected by consumers and does not, therefore, affect consumer

choice. A reduction in mean salt intake of 3g per day for adults (to

achieve a target of 6g daily) would lead to around 20,000 fewer

deaths from CVD annually. That means approximately 130,000

quality-adjusted life years (QALYs) would be gained and around £350

million would be saved in healthcare costs. A reduction of 6g per day

would lead to twice the gain: some 260,000 QALYs and a saving of

£700 million in healthcare costs.

3.28 NICE has made recommendations on helping people to be physically

active in: „Four commonly used methods to promote physical activity‟

(NICE public health guidance 2); „Physical activity and the

environment‟ (NICE public health guidance 8); „Promoting physical

activity in the workplace‟ (NICE public health guidance 13); and

„Promoting physical activity for children and young people‟ (NICE

public health guidance 17). As a result, although these issues are

important in helping to prevent CVD, they are not covered in this

guidance.

3.29 The PDG discussed whether calorie content could be presented on

food labels in terms of the hours of physical activity required to use

them up. It was noted that there was no evidence to support this

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approach. However, the PDG was aware of evidence to support the

idea that presenting the total calorific content on food labels could

help reduce intake (Ludwig and Brownell 2009).

3.30 The PDG discussed the links between sedentary behaviour and

CVD, and the need to encourage people to be more physically active.

However, evidence on how to address sedentary behaviour is not

well developed and remains an area for further study.

Children

3.31 Maternal and fetal nutrition has an important influence on whether or

not people develop CVD later in life. There is a growing body of

evidence that suggests breastfeeding may protect against the

development of risk factors for CVD. For example, it is associated

with small reductions in blood pressure (Martin et al. 2005), serum

cholesterol (Owen et al. 2008), a reduced risk of being overweight

(Harder et al. 2005) or having type 2 diabetes (Owen et al. 2006).

However, the evidence on breastfeeding per se as a means of

preventing CVD is unclear (Martin et al. 2004; Rich-Edwards et al.

2004). While the PDG recognised the benefits of breastfeeding, it

concluded that there was insufficient evidence to make a

recommendation related to CVD prevention. However, NICE‟s

guidance on maternal and child nutrition is referred to in the

recommendations.

3.32 The PDG noted the importance of taking action to prevent the

development of CVD risk factors among children by ensuring they

have a healthy, balanced diet and are physically active. This supports

the principle of „primordial prevention‟ to maintain low cholesterol and

blood pressure throughout life.

Evidence

3.33 Many studies considered in the reviews of effectiveness were carried

out some years ago. The majority were published before 2000, with a

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substantial number published before 1990. This reflects, in part, the

decision to include studies such as the North Karelia and HeartBeat

Wales CVD population-level programmes which took place in the

1970s and 1980s. The age of the studies means a number of factors

have to be taken into account when considering effectiveness. In

particular:

The different risk factor levels for CVD are likely to have

changed. For instance, intake of salt and saturated fat and the

prevalence of smoking may have fallen, while a sedentary

lifestyle and rates of obesity may have increased.

The political and cultural environments which affect the

effectiveness of interventions may have changed substantially.

3.34 There are a number of difficulties when considering evidence of the

effectiveness of population-level interventions:

Changes may have come about inadvertently, for instance, as a

result of a change in agriculture practice following economic

developments – and unrelated to CVD prevention. Any

evaluation of such changes are likely to have been carried out

after the event, using proxy data.

It is often difficult to find a suitable control population where

conditions are relatively similar to those in the intervention

group. Where a control group is used, there are often difficulties

with contamination between the two groups which can lead to an

underestimation of any beneficial effects.

It is ethically and practically impossible to use randomised

controlled trials with country-wide populations. The best

evidence available has to be gleaned from other research

designs in particular, natural experiments, epidemiological

models and cost effectiveness and cost benefit analyses.

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3.35 The potential effect of any intervention may change according to the

initial level of risk. For instance, it may be easier to reduce salt intake

among a population with a high intake than among a population

where intakes of salt are lower. However, epidemiological modelling

suggests that substantial reductions in CVD rates can be achieved by

further reducing the major risk factors as much as possible. This is

the case even in countries where CVD mortality rates are initially

lower, such as Italy (Palmieri et al. 2009).

3.36 The economic modelling was based on conservative assumptions.

Nevertheless, it suggested that the recommended population-based

approaches are likely to be consistently cost saving. .

Other issues

3.37 Many of the risk factors that the PDG considered are significant for a

number of other health-related conditions – not just CVD – including

some common cancers, respiratory diseases, obesity, diabetes,

kidney diseases and mental wellbeing. The prevention strategies

discussed in this guidance are likely to help prevent some of these

other health conditions. (Certainly, they are not likely to increase the

risk of any other common chronic diseases.) However, it was not

possible to consider each of these other health conditions in detail.

3.38 This guidance focuses on salt, trans fats and saturated and poly

unsaturated fats. However, the PDG emphasised its support for a

healthy diet, as advocated in the „eatwell‟ plate (Food Standards

Agency 2007).

3.39 Daily consumption of products containing plant sterols and stanols

may reduce blood cholesterol by about 10% – and so may have a

substantial impact on CVD mortality. However, it was not clear how a

recommendation on their use might impact on inequalities in health.

The PDG believes this issue deserves further attention.

3.40 Agricultural and transport policy and practice (and other similar

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issues) have a powerful impact on people‟s diet and physical activity

levels. They also impact on climate change and sustainable

development (which, in turn, can affect health). The PDG did not

consider either climate change or sustainable development as these

issues were beyond the scope of this guidance.

This section will be completed in the final document.

4 Recommendations

When writing the recommendations, the Programme Development Group

(PDG) (see appendix A) considered the evidence of effectiveness and cost

effectiveness. Note: this document does not constitute NICE‟s formal

guidance on these programmes. The recommendations are preliminary and

may change after consultation.

The evidence statements underpinning the recommendations are listed in

appendix C.

The evidence reviews, supporting evidence statements and economic

analysis are available at www.nice.org.uk/guidance/PHG/Wave17/26

Population versus individual approach

Changes in cardiovascular disease (CVD) risk factors can be brought about

by intervening at a number of different levels. Although interventions focused

on changing individual behaviour have tended to dominate in recent years,

population-level changes could lead to the greatest overall benefit. Such

changes may be achieved through „upstream‟ interventions: national or

regional policy and legislation and action aimed at improving the physical,

social and economic environments. (For more on the importance of

interventions aimed at the whole population, see considerations 3.2, 3.3, 3.5,

3.6 and 3.9.)

The policy recommendations (recommendations 1 to 11) are based on

extensive and consistent evidence which suggests that these changes are

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likely to be the most effective and cost effective way of reducing CVD among

the population.

Government has addressed – and continues to address – cardiovascular

disease at a population and individual level. The recommendations in this

guidance are based on a robust analysis of the evidence for action and

provide a national framework for action. Implementation will involve

government, industry and key non-governmental organisations. Any action to

be taken by government will be prioritised following the usual processes.

The recommendations for practice (recommendations 12 to 24) support and

complement – and are supported by – these policy changes.

Recommendations for policy

Who should take action?

The following officials, government departments and national agencies should

be involved:

Chief Medical Officer

National Clinical Director for Coronary Heart Disease

Chief Scientist

Department for Business, Innovation and Skills

Department for Culture, Media and Sport

Department for Children, Schools and Families

Department for Environment, Food and Rural Affairs

Department for Transport

Department of Communities and Local Government

Department of Health

Food Standards Agency

HM Treasury

National Institute for Health Research

Ofcom

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Other research organisations (for example, the Medical Research Council

and the Economic and Social Research Council).

Other key players include:

food and drink manufacturers

food and drink retailers

caterers

the farming sector

national, non-governmental organisations including, for example, the British

Heart Foundation, Cancer Research UK, Diabetes UK, National Heart

Forum, the Stroke Association and other chronic disease charities.

Recommendation 1: common agricultural policy

The common agricultural policy (CAP) is the overarching framework used by

European Union member countries to form their own agricultural policies.

However, it introduces a number of significant distortions, including on certain

food prices in the EU. Ongoing reform of the CAP should remove such

distortions and provide a basis for supporting other government action on

preventing CVD in the UK. There is sufficient evidence to suggest that the

CAP could now be reviewed to support the prevention of CVD. The evidence

suggests that the following are among the measures that could be considered.

What action could be taken?

Negotiate to amend the common agricultural policy (CAP) to ensure it takes

account of public health issues. Specifically, food growing and production

should be linked to healthy eating guidelines, such as the „eatwell plate1‟.

Negotiate to ensure the European Commission‟s (EC) impact assessment

procedure (part of its strategic planning and programming cycle) takes the

effect on cardiovascular health into account.

1 Food Standards Agency (2007) Eatwell plate [online]. Available from

www.eatwell.gov.uk/healthydiet/eatwellplate

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Ensure fiscal incentives and disincentives for industry support the

production of low saturated, as opposed to full-fat, dairy products and fruit,

vegetables and cereals for human consumption.

Ensure reduced-fat dairy products are cheaper than their full-fat

equivalents.

Recommendation 2: product labelling and marketing

A framework of legislation and regulation affects consumer behaviour. The

evidence suggests that, in the context of product labelling and marketing, the

following measures could be considered.

What action could be taken?

Develop legislation to implement the Food Standards Agency‟s Integrated

Label for products sold in England. This includes traffic light colour-coding,

text to indicate „high‟, „medium‟ or „low‟ content of particular ingredients and

the percentage guideline daily amount (GDA). Implement the system in

advance of legislation.

Restrict advertising for products that fall into the amber and red categories

of the Food Standards Agency‟s food labelling system.

Clearly label products requiring a high salt content (such as some cheeses

and meat products) to indicate that they are high in salt and should only be

considered for occasional consumption.

Recommendation 3: salt

High levels of salt in processed food have a major impact on the total amount

consumed by the population. This, in turn, can cause high blood pressure

which is a CVD risk factor. Industry has made considerable progress in

reducing salt in everyday foods. However, the rate of progress is too slow

and, as a matter of priority, needs to be accelerated. The evidence suggests

that the following are among the measures that could be considered to reduce

salt content further.

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What action could be taken?

Reduce population salt intake to no more than 6g per day initially (and to a

lower level in the longer term). This can be achieved by promoting the

benefits to the EU and introducing national legislation.

Continue to reduce the salt content of commonly consumed foods (bread,

meat products, cheese, soups and breakfast cereals) by persuading

manufacturers to progressively change their recipes and production

methods. All food products available throughout the EU should be subject

to these changes, including low cost, standard and luxury goods.

Agree EU salt targets for processed foods. Ensure salt levels are monitored

in commonly consumed foods. Monitoring should take place at EU level

and nationally.

Reinforce national targets for salt intake among the population and review

them at regular intervals. This includes developing a timetable to meet the

voluntary targets on the level of salt used in common foods. Set a deadline

for the development of mandatory regulations if progress is not being

achieved.

Develop fiscal incentives and disincentives to encourage manufacturers to

make low salt products cheaper than their higher salt equivalents.

Impose VAT at the standard rate on culinary quality salt, as part of a

consistent policy to ensure taxation is used to reduce the risk of CVD.

Recommendation 4: saturated fats

Halving the average intake of saturated fats (from 14% to 7% of total energy)

might prevent approximately 30,000 CVD deaths annually. The evidence

suggests that the following are among the measures that could be considered.

What action could be taken?

Offer subsidies to encourage manufacturers to make low saturated fat

products cheaper than the higher saturated equivalent.

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Introduce legislation (for example in relation to VAT) to make high

saturated fat products more expensive than the lower saturated fat

equivalent.

Introduce legislation (for example, in relation to VAT) to make fruit and

vegetables and other foods that make up a healthy diet cheaper than less

healthy products.

Reformulate all products (particularly those sold as low priced „value‟

ranges) to reduce the amount of saturated fat they contain and remove

trans fats.

Recommendation 5: trans fats

Trans fats constitute a significant health hazard. As part of the proposed CVD

prevention framework, it would be beneficial to eliminate them altogether from

the national diet. The evidence suggests that the following are among the

measures that could be considered.

What action could be taken?

Ban the use of industrial trans fats for human consumption throughout the

EU.

Revise the current UK and international recommendation on trans fatty

acids, so that they account for less than 0.5% of daily energy value for all

groups – not just for the population mean. Develop a timetable for action

that includes the introduction of legislation if there is no other way to

achieve this in a timely fashion.

Replace trans fatty acids with vegetable oils high in polyunsaturated and

monounsaturated fatty acids. Ensure saturated fats are not used to replace

trans fats.

Independently monitor the level of trans fats in processed and take-away

food to identify consumption in all sectors of the population, rather than

relying on an average figure.

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Recommendation 6: catering guidelines

Public sector organisations are important providers of food and drink to large

sections of the population. An effective way to reduce the risk of CVD would

be to improve the nutritional quality of the food and drink they provide. The

evidence suggests that the following are among the measures that could be

considered.

What action could be taken?

Ensure Food Standards Agency-approved dietary guidelines in publicly-

funded settings such as schools, hospitals and public sector work canteens

are achieved.

Develop a timetable to implement the voluntary „Healthy Food Mark‟

scheme. Set a deadline for the development of mandatory regulation if

progress is not being achieved.

Recommendation 7: take-aways and other food outlets

Food from take-aways and other outlets comprises a significant part of many

people‟s diet. Local planning authorities are able to control fast-food outlets

and it is up to them to use their powers to take effective local action.

Regulation of the outlets selling this food would provide another opportunity to

tackle the risk of CVD. The evidence suggests that the following are among

the measures that could be considered.

What action could be taken?

Ensure local planning authorities understand existing legislation which

enables local authorities to refuse planning permission for take-aways and

other food retail outlets in specific areas (for example, near schools).

Ensure the legislation is widely implemented. (See also

recommendation12.)

Link this legislation to licensing and food hygiene regulations.

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Recommendation 8: active travel

Travel offers an important opportunity to help people become more physically

active. However, inactive modes of transport have increasingly dominated in

recent years. The evidence suggests that the following are among the

measures that could be considered.

What action could be taken?

Use fiscal incentives and disincentives to promote physical activity including

physically active travel to and at work. For example:

exempt VAT on sports and exercise equipment, cycles and related

equipment used at work

place direct taxes on the provision of car parking used as a benefit.

Recommendation 9: health impact assessment

Health impact assessment is a well-developed method of determining the

likely health consequences of particular policies, initiatives or actions. It is

important to ensure this approach is applied as a routine part of the policy

development process. The evidence suggests that the following are among

the measures that could be considered.

What action could be taken?

Assess all public policy for its potential impact (positive and negative) on

cardiovascular disease and other related chronic diseases. In addition,

assess its potential impact on health inequalities. Assessments should be

carried out using health and policy impact assessment and other similar,

existing tools.

Make health impact assessments mandatory for all public policy. Monitor

the outcomes of policy following the assessment and use them to follow up

and amend future plans.

Regularly and independently monitor the consumption of salt, trans fatty

acids, saturated fatty acids, mono and polyunsaturated fatty acids. Use

industry data (including consumer purchasing data) and population

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surveys. Ensure there is continuous progress towards a healthy level of

consumption of these nutrients.

Recommendation 10: commercial interests

Food and drink manufacturers and retailers have a particularly important role

in helping to prevent CVD. Some responsible commercial organisations are

already taking positive action. The evidence suggests that the following are

among the measures that could be considered.

What action could be taken?

Introduce a similar framework for food and drink production to that adopted

by the World Health Organization for tobacco control (that is, „Framework

convention on tobacco control‟ [2003]).

Develop an international public health information system (resembling

GLOBALink2) for CVD prevention.

Ensure all meetings, including lobbying, between the food and drink

industry and government and government agencies are conducted in a

transparent way.

Ensure disclosure rules are followed including declarations of interests (for

example, on past employment and consultancy work).

Recommendation 11: children

Eating and drinking patterns get established at an early age, so measures to

protect children from the dangers of a poor diet should be given serious

consideration. The evidence suggests that the following are among the

measures that could be considered.

What action could be taken?

Vigorously protect children and young people from marketing which promotes

an unhealthy diet by:

2 www.globalink.org

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Developing an agreed framework of principles for food marketing aimed at

children. This could be similar to the „Sydney principles3‟. The framework

should be comprehensive and should be based on children‟s rights to a

healthy diet.

Banning the advertising of foods high in fat, salt and sugar (as determined

by the Food Standards Agency nutrient profile) on TV and other broadcast

media including new technologies (such as the Internet or mobile phones).

Developing standards, supported by legislation, to provide controls for non-

broadcast media.

Recommendations for practice

Recommendation 12: take-aways and other food outlets

Who is the target population?

Take-aways and other food outlets.

Who should take action?

Local government.

What action should they take?

Introduce bye-laws to regulate the opening hours of take-aways and other

food outlets near schools.

Use existing powers to set limits for the number of take-aways and other

food outlets in a given area. Directives could specify the distance from

schools and the number that can be located in certain areas.

Recommendation 13: health impact assessment

Who is the target population?

Whole population.

3 Swinburn B, Sacks G, Lobstein T et al. (2007) The „Sydney principles‟ for reducing the

commercial promotion of foods and beverages to children. Public Health Nutrition: 11 (9): 881–6.

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Who should take action?

Regional and local government.

Local policy makers.

What action should they take?

Assess the potential impact (positive and negative) that all local plans will

have on rates of CVD and related chronic diseases, including any potential

impact on health inequalities. Use existing tools such as health impact

assessments.

Monitor the outcomes following a health impact assessment and use this to

follow up and amend plans.

Recommendation 14: training

Who is the target population?

Caterers.

Who should take action?

Local authorities.

Providers of hygiene training.

What action should they take?

Ensure the links between nutrition and health are a mandatory part of hygiene

training for caterers. In particular, training should cover the adverse effect that

salt, industrial trans fats and saturated fats can have on health. It should also

cover the healthy alternatives to these ingredients, based on the „eatwell

plate4‟.

4 Food Standards Agency (2007) Eatwell plate [online]. Available from

www.eatwell.gov.uk/healthydiet/eatwellplate/

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Recommendation 15: public sector food provision

Who is the target population?

Anyone who eats meals provided by public sector organisations.

Who should take action?

Local authorities.

NHS organisations.

Education authorities.

Prison services.

Emergency services.

What action should they take?

Procure and provide meals for people working in the public sector (and for

others in receipt of meals provided by public services) that:

are low in salt and saturated fats

are nutritionally balanced and varied, in line with recommendations made in

the „eatwell plate5‟

do not contain industrial trans fats

are clearly labelled.

Recommendation 16: children and young people

Who is the target population?

Children and young people under the age of 16 years.

Who should take action?

Parents and carers of children and young people under the age of 16

years.

5 Food Standards Agency (2007) Eatwell plate [online]. Available from

www.eatwell.gov.uk/healthydiet/eatwellplate/

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Nursery nurses and workers in pre-school day care settings such as

nurseries.

Local authorities.

Schools (governors and teachers).

Catering staff.

What action should they take?

Help children to have a healthy diet and to develop positive, life-long habits

in relation to food. This can be achieved by ensuring the messages

conveyed about food, the food and drink available and where it is

consumed is conducive to a healthy diet. (For more details, see NICE

public health guidance 11 on maternal and child nutrition at

www.nice.org.uk/PH11)

Local authorities should ensure cinemas, fun parks and other places where

children congregate for entertainment and recreation provide a range of

affordable healthy snacks and drinks. This includes the food and drinks

provided in vending machines.

Recommendation 17: local and regional policy

Who is the target population?

Whole population.

Who should take action?

Local authority planning departments.

Government regional offices.

What action should they take?

Align Section 106 funding („planning gain‟) with the promotion of heart health

to ensure there is funding to support physically active travel and to give

people in disadvantaged areas access to affordable fruit and vegetables.

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Recommendation 18: physical activity

Who is the target population?

Whole population.

Who should take action?

Local authorities.

What action should they take?

Ensure cycle tracks are part of the definitive map (the legal record of public

rights of way).

Prioritise the needs of pedestrians and cyclists over motorists when

developing or redeveloping streets.

Make it mandatory for public sector employers to provide staff with

workplace travel plans incorporating physical activity. Make it a voluntary

option for other large employers.

Audit and abolish bye-laws that prohibit physical activity in public spaces.

Consider offering free swimming to parents and carers who accompany

children aged under 5 years (children under 5 already go free).

Allocate part of the budget for road building to promote walking, cycling and

other forms of travel that involves physical activity.

Recommendations for practice: regional CVD prevention

programmes (19–24)

Who is the target population?

Whole population.

Who should take action?

Primary care trusts.

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Local authorities.

Directors of public health.

Local partnerships (such as those responsible for local area agreements).

Government regional offices.

Non-governmental organisations including charities and community groups.

Recommendation 19: key elements

What action should they take?

Introduce a programme of intense, multi-component interventions to reduce

the risk of cardiovascular disease. This should comprise five elements:

preparation, programme development, resources, leadership and

evaluation.

Introduce CVD programmes to coincide with the introduction of national

policies, as identified in recommendations 1 to 10.

Recommendation 20: preparation

What action should they take?

Gain a good understanding of the nature and extent of CVD in the

community and any previous CVD prevention initiatives that have been run

in the area (including any positive or negative experiences). This includes

the community‟s exposure to current (and potential) risk factors.

Gauge the community‟s level of knowledge about CVD risk factors and

people‟s confidence in their ability to change their behavior to reduce those

risks.

Identify groups of the population who are disproportionately affected by

CVD and develop strategies to address their needs.

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Take into account the community‟s exposure to risk factors (those currently

facing adults and those emerging for children and younger people).

Recommendation 21: programme development

What action should they take?

Develop a population-based approach, as well as strategies for targeting

people at particularly high risk of CVD.

Take account of ongoing, accredited screening activities by GPs and other

healthcare professionals.

Only develop, plan and implement a strategic, integrated media campaign

as part of a wider package of interventions to address CVD risk factors.

This should be based on an acknowledged theoretical framework.

When developing CVD programmes, take account of NICE recommendations

within the following guidance: „Brief interventions and referrals for smoking

cessation‟ (NICE public health guidance 1); „Four commonly used methods to

increase physical activity‟ (NICE public health guidance 2); „Workplace

interventions to promote smoking cessation‟ (NICE public health guidance 5);

„Behaviour change‟ (NICE public health guidance 6); „Physical activity and the

environment‟ (NICE public health guidance 8); „Community engagement‟

(NICE public health guidance 9); „Smoking cessation services‟ (NICE public

health guidance 10); „Maternal and child nutrition‟ (NICE public health

guidance 11); „Promoting physical activity in the workplace‟ (NICE public

health guidance 13); and „Physical activity and children‟ (NICE public health

guidance 17).

Recommendation 22: resources

What action should they take?

Ensure CVD prevention programmes are adequately staffed. Avoid adding

CVD prevention activities to the workload of existing staff without relieving

them of other tasks.

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Ensure interventions are sustainable beyond the end of the research or

evaluation period by providing adequate resources.

Ensure volunteers are an additional (rather than a core) resource and that

support for volunteers is adequately resourced.

Ensure steps are taken to retain effective staff.

Ensure recruitment of staff and volunteers from the community is sensitive

to local culture and needs.

Recommendation 23: leadership

What action should they take?

Implement a leadership structure within the CVD programme. This includes

identifying links with the leaders of other relevant organisations.

Identify people to lead the programme, including people from the local

community. Identify in advance – and provide for – the training and other

needs of these potential leaders.

Develop systems to ensure the CVD programme works effectively with

other organisations involved in CVD prevention. This includes ensuring

senior staff are involved, as appropriate.

Recommendation 24: evaluation

What action should they take?

Ensure evaluation is an integral part of the CVD programme.

Ensure appropriate methods are used to evaluate its processes, outcomes

and measures or indicators. Ensure the results of evaluation are

incorporated into future activities.

The PDG considers that all the recommended measures are cost effective.

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For the research recommendations and gaps in research, see section 6 and

appendix D respectively.

5 Implementation

NICE guidance can help:

National and local organisations within the public sector meet government

indicators and targets to reduce health inequalities and improve health.

NHS organisations, social care and children's services meet the

requirements of the DH's 'Operating framework for 2009/10' and

'Operational plans 2008/09–2010/11'.

NHS organisations, social care and children's services meet the

requirements of the Department of Communities and Local Government's

'The new performance framework for local authorities and local authority

partnerships'. This includes reducing levels of childhood obesity (PSA

delivery agreement 12). It also includes promoting better health and

wellbeing for all, by reducing all-age, all-cause mortality rates and reducing

smoking prevalence (PSA delivery agreement 18).

Local authorities, NHS and national organisations to fulfill their

responsibilities under the „National service framework for coronary heart

disease‟ (DH 2000).

NHS organisations implement the „NHS health check: vascular risk

assessment‟ and „Management best practice guidance‟ (DH 2009).

National government, local authorities and national organisations fulfill their

responsibilities regarding restricting the availability of tobacco as part of the

Tobacco – Health Bill 2009, the Health Act 2006 (smokefree premises,

places and vehicles), and the Children and Young Persons (Sale of

Tobacco etc.) Order 2007.

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Local authorities and NHS organisations fulfill their responsibility to

increase local opportunities for physical activity, as outlined in „Choosing

health – making healthy choices easier‟ (DH 2005), „Choosing activity: a

physical activity action plan‟ (DH 2005) and the „Walking and cycling: an

action plan‟ (Department for Transport 2004).

NHS organisations and other local public sector partners fulfil their remit to

promote the economic, social and environmental wellbeing of communities.

It can also help them to benefit from any identified cost savings,

disinvestment opportunities or opportunities for redirecting resources.

NHS and local authority organisations meet the requirements of „Delivering

choosing health – making healthy choices easier‟ (DH 2005).

NICE will develop tools to help organisations put this guidance into practice.

Details will be available on our website after the guidance has been issued

(www.nice.org.uk/PHxx).

6 Recommendations for research

This section will be completed in the final document.

More detail on the gaps in the evidence identified during development of this

guidance is provided in appendix D.

7 Updating the recommendations

This section will be completed in the final document.

8 Related NICE guidance

Published

Promoting physical activity for children and young people. NICE public health

guidance 17 (2009). Available from www.nice.org.uk/PH17

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Cardiovascular risk assessment and the modification of blood lipids for the

primary and secondary prevention of cardiovascular disease. NICE clinical

guideline 67 (2008). Available from www.nice.org.uk/CG67

Identifying and supporting people most at risk of dying prematurely. NICE

public health guidance 15 (2008). Available from www.nice.org.uk/PH15

Preventing the uptake of smoking by children and young people. NICE public

health guidance 14 (2008). Available from www.nice.org.uk/PH14

Promoting physical activity in the workplace. NICE public health guidance 13

(2008). Available from www.nice.org.uk/PH13

Maternal and child nutrition. NICE public health guidance 11 (2008). Available

from www.nice.org.uk/PH11

Smoking cessation services. NICE public health guidance 10 (2008).

Available from www.nice.org.uk/PH10

Community engagement. NICE public health guidance 9 (2008). Available

from www.nice.org.uk/PH9

Physical activity and the environment. NICE public health guidance 8 (2008).

Available from www.nice.org.uk/PH8

Behaviour change. NICE public health guidance 6 (2007). Available from

www.nice.org.uk/PH6

Workplace interventions to promote smoking cessation. NICE public health

guidance 5 (2007). Available from www.nice.org.uk/PH5

Four commonly used methods to increase physical activity. NICE public

health guidance 2 (2006). Available from www.nice.org.uk/PH2

Brief interventions and referral for smoking cessation in primary care and

other settings. NICE public health guidance 1 (2006). Available from

www.nice.org.uk/PH1

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Obesity: the prevention, identification, assessment and management of

overweight and obesity in adults and children. NICE clinical guideline 43

(2006). Available from www.nice.org.uk/CG43

Under development

Alcohol use disorders (prevention). NICE public health guidance (publication

expected March 2010).

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Appendix A Membership of the Programme

Development Group (PDG), the NICE project team and

external contractors

Programme Development Group

PDG membership is multidisciplinary, comprising public health practitioners,

clinicians (both specialists and generalists), local authority officers, teachers,

social care professionals, representatives of the public, patients, carers,

academics and technical experts as follows.

Pamela Ashton Community Member

Andrew Briggs Chair of Health Policy and Economic Evaluation, University of

Glasgow

Simon Capewell (Vice Chair) Professor of Clinical Epidemiology, University

of Liverpool; Honorary Consultant in Public Health, Liverpool PCTs

Francesco Cappuccio Chair of Cardiovascular Medicine and Epidemiology,

Clinical Sciences Research Institute, University of Warwick Medical School;

Honorary Consultant Physician, University Hospitals Coventry and

Warwickshire NHS Trust, Coventry

Martin Caraher Reader in Food and Health Policy, Centre for Food Policy,

City University

Charlie Foster Senior Researcher, Health Promotion Research Group, British

Heart Foundation

Paramjit Gill GP and Clinical Reader in Primary Care Research, Primary

Care Clinical Sciences, University of Birmingham; Honorary Consultant in

Primary Care, Heart of Birmingham Teaching PCT

Robin Ireland Chief Executive, Heart of Mersey

Paul Lincoln Chief Executive, National Heart Forum

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Klim McPherson (Chair) Visiting Professor of Public Health Epidemiology,

University of Oxford

Madeleine Murtagh Senior Lecturer in Social Science and Public Health,

School of Population and Health Sciences, Newcastle University

Margaret O’Mara Community Member (attended meetings 1 to 3 only)

Kiran Patel Consultant Cardiologist and Honorary Senior Lecturer in

Cardiovascular Medicine, University of Birmingham, Sandwell and West

Birmingham NHS Trust

Suzannah Power Community Member

Ian Reekie Community Member

Sian Robinson Principal Research Fellow, Medical Research Council

Epidemiology Research Centre, University of Southampton

John Soady Public Health Principal, Directorate of Public Health, NHS

Sheffield

Margaret Thorogood Professor of Epidemiology, Warwick Medical School,

University of Warwick

Valerie Woodward Senior Lecturer, University of Wolverhampton

NICE project team

Mike Kelly

CPHE Director

Jane Huntley, Catherine Swann

Associate Directors

Hugo Crombie

Lead Analyst

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Andrew Hoy

Analyst

Patti White

Analyst

Susan Murray

Analyst

Lorraine Taylor

Analyst

Caroline Mulvihill

Analyst

Bhash Naidoo

Technical Adviser Health Economics

External contractors

Evidence reviews

Review 1: „Prevention of cardiovascular disease at population level (Question

1; phase 1)‟ was carried out by the West Midlands Health Technology

Assessment Collaboration (WMHTAC), University of Birmingham. The

principal authors were: Mary Pennant, Wendy Greenheld, Anne Fry-Smith,

Sue Bayliss, Clare Davenport and Chris Hyde.

Review 2: „Prevention of cardiovascular disease at population level (Question

1; phase 2)‟ was carried out by WMHTAC, University of Birmingham. The

principal authors were: Mary Pennant, Wendy Greenheld, Anne Fry-Smith,

Sue Bayliss, Clare Davenport and Chris Hyde.

Review 3: „Prevention of cardiovascular disease at population level (Question

1; phase 3)‟ was carried out by WMHTAC, University of Birmingham. The

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principal authors were: Mary Pennant, Wendy Greenheld, Anne Fry-Smith,

Sue Bayliss, Clare Davenport and Chris Hyde.

Review 4: „Barriers to, and facilitators for, the effectiveness of multiple risk

factor programmes aimed at reducing cardiovascular disease within a given

population: a systematic review of qualitative research‟ was carried out by the

Peninsula Technology Assessment Group at the Peninsula Medical School,

Universities of Exeter and Plymouth. The principal authors were: Ruth

Garside, Mark Pearson, Kate Ashton, Tiffany Moxham and Rob Anderson.

Primary research

Review 5: ‟Population and community programmes addressing multiple risk

factors to prevent cardiovascular disease: A qualitative study into how and

why some programmes are more successful than others‟ was carried out by

the Peninsula Technology Assessment Group at the Peninsula Medical

School, Universities of Exeter and Plymouth. The principal authors were: Ruth

Garside, Mark Pearson, Tiffany Moxham, and Rob Anderson.

Economic analysis

Review 6: „Prevention of cardiovascular disease at population level (Question

1; cost-effectiveness)‟ was carried out by WMHTAC, University of

Birmingham. The principal authors were: Lazaros Andronis, Pelham Barton,

Sue Bayliss and Chris Hyde.

Modelling report: „Prevention of cardiovascular disease at population level:

modelling strategies for primary prevention of cardiovascular disease‟ was

carried out by WMHTAC, University of Birmingham. The principal authors

were: Pelham Barton and Lazaros Andronis.

Expert reports

Report 1: „The effectiveness of physical activity promotion interventions‟ was

carried out by Charlie Foster, British Heart Foundation Health Promotion

Research Group.

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Report 2: „Health policy analysis‟ was carried out by Mark Exworthy, School of

Management, Royal Holloway University of London.

Report 3: „Expert testimony on salt and cardiovascular disease‟ was carried

out by Francesco Cappuccio, Clinical Sciences Research Institute, University

of Warwick Medical School.

Report 4: „The relationship between commercial interests and risk of

cardiovascular disease‟ was carried out by Jane Landon, National Heart

Forum.

Report 5: „Regional development of a population-based collaborative CVD

prevention strategy: the experience of NHS West Midlands‟ was carried out by

Kiran Patel, University of Birmingham and West Midlands Strategic Health

Authority.

Report 6: „NICE guidance on the prevention of CVD at population level:

evidence from the Co-operative Group‟ was carried out by Cathryn Higgs, the

Co-operative Group.

Report 7: „Population and community programmes addressing multiple risk

factors to prevent cardiovascular disease (CVD): addendum to qualitative

study produced by Peninsula Technology Assessment Group for NICE: CVD

programme – Heart of Mersey (HoM)‟ was carried out by Robin Ireland, Heart

of Mersey.

Report 8: „Expert testimony paper on the independent evaluation of “have a

heart Paisley” phase one (Scotland‟s national CHD prevention demonstration

project)‟ was carried out by Avril Blamey, Avril Blamey and Associates.

Report 9: „Expert testimony on the public health harm caused by industrially

produced trans fatty acids and actions to reduce and eliminate them from the

food system in the UK‟ was carried out by Paul Lincoln, National Heart Forum.

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Report 10: „Prevention of cardiovascular disease at a population level:

evidence on interventions to address dietary fats‟ was carried out by Modi

Mwatsama, Heart of Mersey.

Report 11: „CVD risk factors: paradigms and pathways‟ was carried out by

Simon Capewell, University of Liverpool.

Report 12: „CVD prevention in populations: lessons from other countries‟ was

carried out by Simon Capewell, University of Liverpool.

Report 13: „Will CVD prevention widen health inequalities?‟ was carried out by

Simon Capewell, University of Liverpool.

Report 14: „Food manufacturer‟s perspective‟ was carried out by Frances

Swallow and Nicola Currie, Greencore.

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Appendix B Summary of the methods used to develop

this guidance

Introduction

The reviews, expert reports and economic analysis include full details of the

methods used to select the evidence (including search strategies), assess its

quality and summarise it.

The minutes of the PDG meetings provide further detail about the Group‟s

interpretation of the evidence and development of the recommendations.

All supporting documents are listed in appendix E and are available at

www.nice.org.uk/guidance/PHG/Wave17/26

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Guidance development

The stages involved in developing public health programme guidance are

outlined in the box below.

1. Draft scope released for consultation

2. Stakeholder meeting about the draft scope

3. Stakeholder comments used to revise the scope

4. Final scope and responses to comments published on website

5. Evidence reviews, expert testimony and economic analysis undertaken

6. Evidence and economic analysis released for consultation

7. Comments and additional material submitted by stakeholders

8. Review of additional material submitted by stakeholders (screened against

inclusion criteria used in reviews)

9. Evidence and economic analysis submitted to PDG

10. PDG produces draft recommendations

11. Draft guidance released for consultation and for field testing

12. PDG amends recommendations

13. Final guidance published on website

14. Responses to comments published on website

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Key questions

The key questions were established as part of the scope. They formed the

starting point for the reviews of evidence and were used by the PDG to help

develop the recommendations.

The overarching questions were:

Which multiple risk-factor interventions are effective and cost effective

in preventing the onset of cardiovascular disease (CVD) within a given

population (primary prevention)?

How does effectiveness and cost effectiveness vary between different

population groups?

The subsidiary question was:

What barriers and facilitators influence the effectiveness of multiple risk-factor

programmes aimed at reducing CVD (or the risk factors associated with CVD)

among a given population (including subgroups experiencing health

inequalities, where the data allows)?

These questions were made more specific for each review (see reviews for

further details).

Single risk factors were considered using expert testimony. See appendix C

for details.

Reviewing the evidence

Three reviews of effectiveness (reviews 1,2,3), one qualitative review (review

4), one primary study of barriers and facilitators (review 5) and one review of

cost effectiveness (review 6) were conducted.

Identifying the evidence

The following databases were searched for randomised controlled trials

(RCTs); controlled before-and-after trials; cohort studies; case–control

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studies; before-and-after studies; and interrupted time series (from 1970

onwards):

ASSIA (Applied Social Science Index and Abstracts)

CINAHL (Cumulative Index of Nursing and Allied Health Literature)

Cochrane Database of Systematic Reviews (CDSR)

Cochrane Library (Wiley)

Database of Abstracts of Reviews of Effects (DARE)

DH-Data

EMBASE

Health Management Information Service (HELMIS)

Health Technology Assessment (HTA)

HMIC (Health Management Information Consortium)

King's Fund Database

MEDLINE

MEDLINE In Process

PsycINFO

The following websites were also searched:

Centre for the Evaluation of Public Health Interventions, London School of

Hygiene & Tropical Medicine www.lshtm.ac.uk/cephi

Cochrane Public Health Group www.ph.cochrane.org/en/index.html

Health evidence http://health-evidence.ca

The Campbell Collaboration www.campbellcollaboration.org

The Evidence for Policy and Practice Information and Coordinating Centre

http://eppi.ioe.ac.uk/cms

Further details of the databases, search terms and strategies used are

included in the review reports.

Selection criteria

Studies were included in the effectiveness reviews if they:

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Involved a population at least the size of one covered by a UK primary care

trust.

Were based in an Organisation for Economic Co-operation and

Development (OECD) country, another developed country or within a World

Health Organization region.

Included primary prevention strategies to tackle at least two of the key risk

factors for CVD.

Studies were excluded if they were:

Confined to populations clinically diagnosed as being at high risk of CVD or

diagnosed with CVD.

Published before 1970.

Not published in English.

Quality appraisal

Included papers were assessed for methodological rigour and quality using

the NICE methodology checklist, as set out in the NICE technical manual

„Methods for the development of NICE public health guidance‟ (see appendix

E). Each study was graded (++, +, –) to reflect the risk of potential bias arising

from its design and execution.

Study quality

++ All or most of the methodology checklist criteria have been fulfilled.

Where they have not been fulfilled, the conclusions are thought very

unlikely to alter.

+ Some of the methodology checklist criteria have been fulfilled. Those

criteria that have not been fulfilled or not adequately described are

thought unlikely to alter the conclusions.

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– Few or no methodology checklist criteria have been fulfilled. The

conclusions of the study are thought likely or very likely to alter.

Economic analysis

The economic analysis consisted of a review of economic evaluations (review

6) and a cost effectiveness analysis.

Review of economic evaluations

The same protocol was used to conduct the literature reviews for all phases of

the review. In a minor departure from the protocol, the list of included study

designs was extended to include cost-consequences.

The following databases were searched from 1970 to August 2008:

ECONLIT

EMBASE

MEDLINE

NHS EED database (Cochrane Library, Wiley).

The search was limited to articles published from 1970 onwards and in the

English language.

In addition to the general bibliographic database searches, specific searches

were conducted for each programme found during the general searches to

ensure all published evaluations, particularly economic evaluations, were

identified.

Study quality was assessed using an evidence form based on the „Methods

for the development of NICE public health guidance‟ (second edition 2009)

and adapted to reflect the parameters of this review. It was supplemented with

questions from the Drummond checklist (Drummond MF [1996] Guidelines for

authors and peer reviewers of economic submissions to the BMJ. London:

BMJ).

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The selection criteria were the same as for the effectiveness reviews (see

pages 53–54). The following study types were included: cost–benefit, cost-

effectiveness and cost–utility analyses.

Modelling

An economic model was constructed to incorporate data from the reviews of

effectiveness and cost effectiveness. The results are reported in: „Prevention

of cardiovascular disease at population level: modelling strategies for primary

prevention of cardiovascular disease‟. It is available on NICE's website at

www.nice.org.uk/guidance/PHG/Wave17/26

Fieldwork

This section will be completed in the final document.

How the PDG formulated the recommendations

At its meetings between September 2008 and July 2009, the PDG considered

the evidence of effectiveness, expert reports and cost effectiveness to

determine:

whether there was sufficient evidence (in terms of quantity, quality and

applicability) to form a judgement

whether, on balance, the evidence demonstrates that the intervention is

effective, ineffective or equivocal

where there is an effect, the typical size of effect.

The PDG developed draft recommendations through informal consensus,

based on the following criteria:

Strength (quality and quantity) of evidence of effectiveness and its

applicability to the populations/settings referred to in the scope.

Effect size and potential impact on the target population‟s health.

Impact on inequalities in health between different groups of the population.

Cost effectiveness (for the NHS and other public sector organisations).

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Balance of risks and benefits.

Ease of implementation and any anticipated changes in practice.

Where possible, recommendations were linked to an evidence statement(s)

(see appendix C for details). Where a recommendation was inferred from the

evidence, this was indicated by the reference „IDE‟ (inference derived from the

evidence).

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Appendix C The evidence

This appendix lists the evidence statements from four reviews, a cost-

effectiveness review and a primary research study provided by external

contractors (see appendix A) and links them to the relevant recommendations.

(See appendix B for the key to quality assessments.)

The evidence statements are presented here without references – these can

be found in the full reviews (see appendix E for details).

The appendix also sets out a brief summary of findings from the economic

analysis.

The four reviews (reviews 1–4), the primary research study (review 5) and the

cost-effectiveness review (review 6) are:

Evidence reviews:

Review 1: „Prevention of cardiovascular disease at population

level (Question 1; phase 1)‟

Review 2: „Prevention of cardiovascular disease at population

level (Question 1; phase 2)‟

Review 3: „Prevention of cardiovascular disease at population

level (Question 1; phase 3)‟

Review 4: „Barriers to, and facilitators for, multiple risk factor

programmes aimed at reducing cardiovascular disease within

a given population: a systematic review of qualitative

research‟

Primary research:

Review 5: ‟Population and community programmes

addressing multiple risk factors to prevent cardiovascular

disease: A qualitative study into how and why some

programmes are more successful than others‟

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Cost-effectiveness review:

Review 6: „Prevention of cardiovascular disease at population

level (Question 1; cost-effectiveness)‟

Evidence statement R3.E1a indicates that the linked statement is numbered

E1a in review 3. Evidence statement R5.12 indicates that the linked

statement is numbered 12 in the primary research study (review 5). Evidence

statement ER1 indicates that the linked statement is from expert report 1.

Evidence statement CE1 indicates that the linked statement is numbered 1

in in the cost-effectiveness review (review 6). „

The reviews, economic analysis and additional evidence are available at

www.nice.org.uk/guidance/PHG/Wave17/26 Where a recommendation is not

directly taken from the evidence statements, but is inferred from the evidence,

this is indicated by IDE (inference derived from the evidence).

Where the PDG has considered other evidence, it is linked to the appropriate

recommendation below. It is also listed in the additional evidence section of

this appendix.

Recommendation 1: evidence statements R3.E5b–h, R4.4.a, R5.10;

additional evidence ER 2, ER 4, ER 7, ER 8, ER 9, ER 10

Recommendation 2: evidence statements R3.E5b–h, R4.9c; IDE

Recommendation 3: evidence statements R3.E1c, R3.E1m, R3.E5b–h,

R5.10; additional evidence ER 3, ER 11, ER 12

Recommendation 4: evidence statements R3.E1b, R3.E1h, R3.E1i–k,

R3.E5b–h, R5.10; additional evidence ER 10, ER 11, ER 12

Recommendation 5: IDE

Recommendation 6: evidence statements R3.E5b–h, R5.10; additional

evidence ER 9, ER 10, ER 11, ER 12

Recommendation 7: evidence statements R3.E3c, R3.E5b–h, R4.18b

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Recommendation 8: evidence statements R3.E3c, R3.E5b–h, R5.10

Recommendation 9: evidence statements R3.E5b–h

Recommendation 10: evidence statements R3.E5b–h, R4.3a, R4.3b;

additional evidence ER 4

Recommendation 11: evidence statements R3.E5b–h, R4.3a, R4.3b, R5.10;

additional evidence ER 4

Recommendation 12: evidence statements R3.E3a, R3.E3c, R4.18a,

R4.18b; additional evidence ER 3, ER 4, ER 9, ER 10

Recommendation 13: IDE

Recommendation 14: evidence statements R4.9e; additional evidence ER 3,

ER 9, ER 10

Recommendation 15: evidence statements R3.E1a–m, R3.E3c, R4.4a,

R4.9e, R4.18a, R4.18b, R4.25e; additional evidence ER 3, ER 9, ER 10

Recommendation 16: evidence statements R3.E5c, R4.18a–c; additional

evidence ER 4

Recommendation 17: additional evidence ER 5, ER 7, ER 8

Recommendation 18: evidence statements R4.1b, R4.3a, R4.3b, R4.7a–c,

R4.8a–d, R4.16a–c, R4.17a–d, R5.3, R5.7, R5.8, R5.9, R5.11, R5.12

Recommendation 19: evidence statements R3.E2a–f, R4.2a–c, R4.17a–d,

R4.18a–c, R4.19a, R4.20a, R4.21a–c, R4.22a, R4.23a–b, R4.24a–d, R4.25a–

d, R4.26a–d, R5.2

Recommendation 20: evidence statements R3.E1a–o, R3.E2a–f, R3.E3a–c,

R4.14a–b, R5.5, R5.7, R5.10, CE 1–9; additional evidence ER 7, ER 8, ER 13

Recommendation 21: evidence statements R4.3a, R4.3b, R4.10a–d,

R4.11a, R4. 11b, R4.12a, R4.13a–d, R4.15a, R4.15b, R5.2, R5.4, R5.6, R5.7

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Recommendation 22: evidence statements R4.1b, R4.7c, R4.10d, R5.2,

R5.3

Recommendation 23: evidence statements R4.16a–c, R5.12

Recommendation 24: evidence statements R3.E1n, R3.E3c, R4.4a, R4.9f,

R4.18a, R4.18c; additional evidence ER 1

Evidence statements

Evidence statement R3.E1a

CVD mortality and morbidity: Limited evidence from 3 out of 38 programme

evaluations using different summary effect measures demonstrate a mixed

effect of multiple risk factor interventions (MRFI) on CVD mortality (the

majority of programmes were beneficial) with two controlled before-and-after

(CBA) studies demonstrating a net decrease in CVD mortality and one

randomised controlled trial (RCT) demonstrating no net change. Limited

evidence from 4 out of 38 programme evaluations, using different summary

effect measures, demonstrate a mixed effect of MRFI on CVD morbidity (the

majority disbeneficial) with one CBA study and one RCT demonstrating a net

increase in morbidity and one RCT demonstrating no net change in morbidity.

The effect of one programme on morbidity and mortality is unclear.

Evidence statement R3.E1b

Blood cholesterol: A large body of evidence from 15 CBA studies and 5 RCTs

demonstrates a mixed direction of effect (majority of programmes beneficial)

of MRFI programmes on blood cholesterol. Fourteen studies (nine CBA and

five RCTs) demonstrate a beneficial net effect. Four CBA studies demonstrate

no net effect or inconclusive net effects and two CBA studies demonstrate a

disbeneficial net effect. The most optimistic result was from a CBA study,

reporting a 0.7mmol/l net reduction in blood cholesterol. The least optimistic

result was from a CBA study, reporting a +0.5mmol/l net increase in blood

cholesterol.

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Evidence statement R3.E1c

Diastolic and systolic blood pressure: A large body of evidence demonstrates

a mixed direction of effect (majority of programmes beneficial) in favour of

MRFI programmes on diastolic and systolic blood pressure. Fourteen CBA

studies and five RCTs demonstrate a mixed direction of effect (majority of

programmes beneficial) on diastolic blood pressure. Twelve studies (seven

CBA studies and five RCTs) demonstrate a beneficial net effect. Five CBA

studies demonstrate no net effect or inconclusive net effects and two CBA

studies demonstrate a disbeneficial net effect. The most optimistic result was

from a CBA study, reporting a 5.5mmHg net reduction in diastolic blood

pressure. The least optimistic result was from a CBA study, reporting a

6mmHg net increase in diastolic blood pressure. Fourteen CBA studies and

five RCTs demonstrate a mixed effect (majority of programmes beneficial) on

systolic blood pressure. Ten studies (five CBA studies and five RCTs)

demonstrate a beneficial net effect. Five CBA studies demonstrate no net

effect or inconclusive net effects and four CBA studies demonstrate a

disbeneficial net effect. The most optimistic result was from a CBA study,

reporting an 11.8 mmHg net reduction in systolic blood pressure. The least

optimistic result was from a CBA study, reporting a 5mmHg net increase in

systolic blood pressure.

Evidence statement R3.E1d

Smoking: A large body of evidence from twenty CBA studies and four RCTs

demonstrate a mixed effect of MRFI on smoking prevalence (the majority of

programmes beneficial). Twelve studies (nine CBA studies and three RCTs)

demonstrate a beneficial net effect. Seven studies (six CBA studies and one

RCT) demonstrate no net effect or inconclusive net effects and five CBA

studies demonstrate a disbeneficial net effect. The most optimistic result was

from a CBA study, reporting an 18.6% net reduction in smoking prevalence.

The least optimistic result was from a CBA study, reporting a 12.8% net

increase in smoking prevalence.

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Evidence statement R3.E1e

BMI: A large body of evidence from fourteen CBA studies and three RCTs

demonstrate a mixed effect of MRFI programmes on body mass index (BMI)

(the majority of programmes beneficial). Ten studies (seven CBA studies and

three RCTs) demonstrate a beneficial net effect. Four CBA studies

demonstrate no net effect or inconclusive net effects and three CBA studies

demonstrate a disbeneficial net effect. The most optimistic result was from a

CBA study, reporting a 1.3kg/m2 net reduction in BMI. The least optimistic

result was from a CBA study, reporting a 0.7kg/m2 net increase in BMI.

Evidence statement R3.E1f

Blood glucose: Limited evidence from 3 out of 38 programme evaluations,

using different summary effect measures, demonstrate a mixed effect of MRFI

on blood glucose. One RCT and one CBA study report mixed results: net

decreases in men and net increases in women, whilst one CBA study

demonstrates no net effect.

Evidence statement R3.E1g

Triglyceride levels, high-density lipoprotein/low-density lipoprotein (HDL/LDL)

ratio or lipid levels: No evidence has been identified on the effects of MRFI

programmes on triglyceride levels, HDL/LDL ratio or lipid levels.

Evidence statement R3.E1h

Dietary change – low versus high fat spreads: Five CBA studies and one RCT

(+) demonstrate a mixed effect of MRFI programmes on consumption or low

versus high fat spreads (the majority of programmes beneficial). Four studies

(three CBA studies and one RCT) demonstrate a beneficial net effect. One

CBA study demonstrates an inconclusive net effect and one CBA study

demonstrates an unfavourable net effect. The most optimistic result was from

a CBA study, reporting a 24% net reduction in the number of people with high

consumption of fat spread on bread. The least optimistic result was from a

CBA study, reporting a 3.3% net decrease in the use of unsaturated spreading

fats.

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Evidence statement R3.E1i

Dietary change – vegetable versus animal fats for cooking: Four CBA studies

demonstrate a mixed effect of MRFI programmes on the use of vegetable

versus animal fat for cooking (the majority of programmes beneficial). Three

CBA studies demonstrate a beneficial net effect and one CBA study

demonstrates an inconclusive net effect. The most optimistic result was from a

CBA study, reporting a 6% net increase in the use of unsaturated fats for

cooking. The least optimistic result was from a CBA study, reporting a 2% net

decrease in the use of vegetable fats for cooking.

Evidence statement R3.E1j

Dietary change – low versus high fat milk: Five CBA studies and one RCT (+)

demonstrate a mixed effect of MRFI programmes on the consumption of low-

versus high-fat milk (the majority of programmes beneficial). Three CBA

studies and one RCT demonstrate a beneficial net effect and two CBA studies

demonstrate an inconclusive net effect. The most optimistic result was from a

CBA study, reporting a 9% net increase in the use of low fat milk in men. The

least optimistic result was from a CBA study, reporting a 1% net decrease in

the use of low fat milk in women.

Evidence statement R3.E1k

Dietary change – consumption high fat foods: Six CBA studies demonstrate a

mixed effect of MRFI programmes on the percentage of high-fat foods in the

diet (the majority of programmes beneficial). Three CBA studies demonstrate

a beneficial net effect, two CBA studies demonstrate no net effect or

inconclusive net effects and one CBA study demonstrates a disbeneficial net

effect. The most optimistic result was from a CBA study, reporting a 24% net

decrease in saturated fat intake. The least optimistic result was from a CBA

study, reporting a 3.4% net increase in high-fat/junk food consumption.

Evidence statement R3.E1l

Dietary change – consumption of fruit and vegetables and wholemeal bread:

Limited evidence is available on the effects of MRFI programmes on the

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consumption of fruit and vegetables and wholemeal bread (the majority of

programmes beneficial). Three CBA studies demonstrate a mixed effect of

MRFI programmes on the consumption of fruit and vegetables. Two CBA

studies demonstrate a beneficial net effect and one CBA study demonstrates

an inconclusive net effect. The most optimistic result is from a CBA study,

reporting a 9% net increase in the number of people consuming five portions

of fruit and vegetables per day. The least optimistic result is from a CBA

study, reporting a 0.2% net decrease in fruit consumption. Two CBA studies

demonstrate a mixed effect on the consumption of wholemeal bread. One

CBA study demonstrates a beneficial net effect and one CBA study

demonstrates an inconclusive effect. The most optimistic result is from a CBA

study, reporting a 3% increase in children. The least optimistic result is from

the same CBA study, reporting a 0.3% net decrease in adults.

Evidence statement R3.E1m

Dietary change – salt intake: Two CBA studies (one [+] and one [-]) provide

mixed results for the effects of MRFI programmes on salt intake. One CBA

study demonstrates a beneficial net treatment effect and one CBA

demonstrates an inconclusive net treatment effect.

Evidence statement R3.E1n

Physical activity: Evidence from 11 CBA studies and one RCT (+) provide a

mixed pattern for the effect of MRFI programmes on physical activity (the

majority of studies are disbeneficial). Three CBA studies and two RCTs

demonstrate a favourable net effect. Three CBA studies demonstrate

inconclusive net effects and four CBA studies demonstrate a disbeneficial net

effect. The most optimistic result is from a CBA study, reporting an 11.5% net

increase in the number of people doing strenuous physical activity more than

three times per week. The least optimistic result is from a CBA study,

reporting a 6% net decrease in the number of people who were physically

active.

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Evidence statement R3.E1o

Attitudes, knowledge and intentions relating to CVD risk factors: Limited

evidence is available on the effects of MRFI programmes on CVD risk factor

attitudes, knowledge and intention to change. One CBA study and one

uncontrolled before-and-after study suggest beneficial changes in CVD

knowledge following MRFI programmes. One of these studies showed a net

increase in the number of individuals intending to lose weight. No evidence

has been identified on the effects of MRFI programmes on CVD risk factor

attitudes.

Evidence statement R3.E2a

General: Evidence for variation in effectiveness in subgroups of the population

is limited and inconsistently reported across included programmes. There is

no clear pattern with respect to gender, age, ethnicity or measures of

deprivation which may be the result of the limited information available,

confounding and selective reporting.

Evidence statement R3.E2b

Ethnicity: Three programmes report the results of subgroup analysis of

effectiveness according to ethnicity. One uncontrolled before-and-after study

reports lower effectiveness in ethnic minorities in acquisition of CVD

knowledge. One CBA study reports lower effectiveness in ethnic minority

groups for reducing smoking prevalence, reducing BMI and increasing fruit

and vegetable intake and one CBA study reports no difference in

effectiveness according to ethnic group.

Evidence statement R3.E2c

Age: Six programmes report results of subgroup analysis according to age.

Two uncontrolled before-and-after studies report a reduction in effectiveness

in acquisition of CVD knowledge in younger participants and one uncontrolled

before-and-after study reports a reduction in effectiveness in reducing salt

intake in younger participants. One CBA study reports a reduction in

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effectiveness in promoting CVD awareness in older participants. Two CBA

studies report no differences in effectiveness according to age.

Evidence statement R3.E2d

Gender: Seven programmes report results of subgroup analysis according to

gender. Four programmes report a reduction in effectiveness in women

compared to men. One RCT reports a reduction in effectiveness in increasing

physical activity in women compared to men. One uncontrolled before-and-

after study and two CBA studies report a reduction in effectiveness in

reducing smoking prevalence in women compared to men. One CBA study

reports a reduction in effectiveness in reducing cholesterol in women

compared to men. One CBA study reports a reduction in effectiveness in

drinking low-fat compared to high-fat milk in women compared to men. Two

programmes report a reduction in effectiveness in men compared to women.

Two CBA studies report a reduction in effectiveness in promoting CVD

awareness and acquisition of CVD knowledge in men compared to women

and one CBA study reports a reduction in effectiveness in reducing CVD

morbidity and mortality in men compared to women. One CBA study reports

no differences in effectiveness according to gender.

Evidence statement R3.E2e

Social class: Two programmes report results of subgroup analysis according

to social class. One CBA study reports a reduction in effectiveness in reducing

smoking in lower social classes compared to higher social classes. One CBA

study reports no differences in effectiveness according to social class.

Evidence statement R3.E2f

Level of education: One programme reports results of subgroup analysis

according to level of education. One CBA study reports a reduction in

effectiveness in CVD awareness in those relatively more educated.

Evidence statement R3.E3a

Nature of the interventions: Thirty one programmes were concerned with the

effectiveness of population programmes using education and mass media,

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and seven with screening programmes directed at large populations in the

community or primary care. However, 16 of the education and mass-media

programmes contained screening components. Counselling was a key

process in many programmes, undertaken individually in 24 programmes and

amongst groups in 16 programmes. The 38 programmes varied in many other

ways. Programme length ranged from one to over 20 years. The size of the

population addressed ranged from approximately 2500 to over 1 million.

Fourteen of the programmes implemented changes to the environment.

Health departments (n=23) [where n is the number of programmes in which

the organisations indicated were involved], local health committees (n=12),

voluntary organisations (n=11) and community volunteers (n=9) had roles in

programme delivery. Programmes were delivered in a variety of settings

including workplaces (n=12) and schools (n=18).

Evidence statement E.3b

Education and mass-media based programmes compared to screening

based: As indicated this was the most marked contrast between the

programmes. However comparing the effectiveness of the two groups is

complicated:

Many of the education and mass-media based programmes contain

elements of screening.

There are many CVD screening programmes, particularly focused on

moderate or high-risk populations which are not included in this review.

The comparison between the two groups is likely to be confounded by

other factors, a very important one of which is that CBA studies are used to

evaluate most of the education and mass-media based programmes, and

RCTs all the screening based programmes.

With these provisos (and reference to pages 127–31 in report 3), the pattern

of results for the risk factors of cholesterol, blood pressure (BP), smoking and

BMI in the two different groups of programmes are summarised in the table

below:

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Programme type (n=38) Programme result, based on direction of

effect

Beneficial Inconclusive Disbenefical No data Net change in mean total cholesterol in mmol/L

Educ & MM 9 4 2 16 Screening 5 0 0 2

Net change in systolic BP in mmHg

Educ & MM 6 4 4 17 Screening 5 0 0 2

Net change in diastolic BP in mmHg

Educ & MM 7 5 2 17 Screening 5 0 0 2

Net change in BMI in kg/m2

Educ & MM 8 3 3 17 Screening 3 0 0 4

Net change in smoking prevalence in %

Educ & MM 9 6 5 11 Screening 3 1 0 3

Although the results are similar, there does appear to be a more consistent

pattern of benefit in the programmes focusing on screening. As well as the

provisos mentioned above, the following also need to be borne in mind when

taking this observation at face value:

Whether this difference could be accounted for by chance alone.

Whether the difference would persist if the size of the effects could be

taken into account.

Vote counting as a method of summarising the results in a systematic

review is recognised to be the weakest approach.

Evidence statement R3.E3c

Possible variations in effectiveness by other aspects of the nature of the

intervention: Over the three reports, many other plausible reasons for the

noted variation in effectiveness have been identified. These include:

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duration of programme

intensity of programme

use of an underlying theoretical model to inform the design of the

programme

pre-programme investigation of particular risk factors operating in a

population

community involvement in planning and/or design of programme

adaptability of the programme as new challenges emerge

level of integration of the separate components of the programme

inclusion of environmental changes as part of the programme.

Whether any of these factors account for differences in effectiveness which

could not arise by chance alone has not been fully explored, and their

potential importance can neither be confirmed nor refuted. Unfortunately, the

extent to which the differences could ever be satisfactorily explored using the

results from these evaluations is debatable given noted limitations in the

reporting of the precise differences in nature of the programmes and the

amount of statistical information available.

Evidence statement R3.E5b

Gender: Twelve programmes report participation in programme interventions

and/or programme evaluation surveys according to gender. One uncontrolled

before-and-after study, seven CBA studies and two RCTs report lower

participation in evaluation surveys or programme interventions by males.

While two programmes, one CBA study and one RCT, report no gender

differences in participation rates.

Evidence statement R3.E5c

Age: Fifteen programmes report participation in programme interventions

and/or programme evaluation surveys according to age. One uncontrolled

before-and-after study and 13 CBA studies report lower participation in

evaluation surveys or programme interventions by those of younger age whilst

one CBA study reports no difference in participation according to age.

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Evidence statement R3.E5d

Level of education: Seven programmes report participation in programme

interventions and/or programme evaluation surveys according to level of

education. Six CBA studies report lower participation by those relatively less

well educated while one CBA study reports lower participation by those

relatively better educated.

Evidence statement R3.E5e

Social class: Three programmes report participation in programme

interventions and/or programme evaluation surveys according to social class.

One CBA study and two RCTs report lower participation by those of lower

social class.

Evidence statement R3.E5f

Ethnicity: Three programmes report participation in programme interventions

and/or programme evaluation surveys according to ethnicity. Two CBA

studies and one RCT report lower participation by ethnic minority groups.

Evidence statement R3.E5g

Marital status: Three programmes report participation in programme

interventions and/or programme evaluation surveys according to marital

status. Two CBA studies and one RCT report lower participation by those

unmarried or divorced.

Evidence statement R3.E5h

CVD risk: Twelve programmes report participation in programme interventions

and/or programme evaluation surveys according to CVD risk. One

uncontrolled before-and-after study, six CBA studies and three RCTs report

lower participation by individuals at relatively higher CVD risk while one RCT

reports relatively lower participation by individuals at relatively lower CVD risk.

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Evidence statement R4.1b

These suggest that factors influencing success include: time limitations for

projects, leadership, (including difficulties engaging community members at

strategic levels), and cooperation between partner organisations.

Evidence statement R4.2a

Four study reports show conflicting evidence about the degree and methods

of community engagement important for success.

Evidence statement R4.2b

For programmes that were successful, one study reports that positive

community expectations about the potential of the programme to effect wider

change facilitated community engagement. It is suggested that insufficient

community engagement did not significantly impact on another programme‟s

success.

Evidence statement R4.2c

For programmes that were unsuccessful, one study reports that previous

negative experiences of community programmes discouraged community

engagement. Conversely, another study reports engagement in the

programme increased willingness for future involvement.

Evidence statement R4.3a

There is evidence from five study reports that community programmes to

address heart health can be affected by the broader political context.

Evidence statement R4.3b

This can effect diverse organisational elements such as: the availability of

project funding, the development of partnerships between organisations and a

sense of shared purpose at different administrative levels. Individual

responses may also be affected through legislation incentives to healthier

behaviours.

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Evidence statement R4.4a

There is evidence from four study reports that high pricing can impact on

people‟s ability and willingness to adopt healthy eating behaviours and to

participate in organised physical activity.

Evidence statement R4.7a

Six study reports discuss factors relating to organisational and strategic

issues.

Evidence statement R4.7b

There is evidence from four studies that short time frames limit the ability to

plan and develop the programme, engage the community, develop

partnerships and communication, meet targets and leave a positive legacy.

Evidence statement R4.7c

Leadership was identified as a key organisational benefit of programmes by

three studies. It is required to develop partnerships and collaborations within

communities, and is important at all levels, from volunteers to with senior

administrators. One study failed to see the desired shift in leadership to the

community itself.

Evidence statement R4.8a

Evidence from six study reports is related to the organisational culture and

partnerships of those involved in CVD programme services.

Evidence statement R4.8b

Three studies note differences in culture between partner organisations

including frames of reference, terminology and programme expectations

although this didn‟t always lead to conflict.

Evidence statement R4.8c

Four studies suggest that CVD programmes are enhanced where partner

organisations have aligned values, priorities, focus and goals between

organisations.

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Evidence statement R4.8d

Partnerships may have positive effects through interagency learning,

increasing the visibility of smaller organisations and enhanced funding

opportunities.

Evidence statement R4.9c

Promotional materials need to be accessible in terms of terminology and

language used.

Evidence statement R4.9e

Two studies note that to sustain the provision of healthier food options,

communities need to take them up and so they need to be made attractive

and clear.

Evidence statement R4.9f

One study found that community projects were largely unwilling address

smoking, preferring to promote physical activity.

Evidence statement R4.10a

Five studies reported on staffing successful programmes.

Evidence statement R4.10b

Three studies report difficulties in recruitment and retention.

Evidence statement R4.10c

Positive staff contributions were defined in three studies where successful

networking allowed staff to use their time effectively because they were not

duplicating activities; where they were assisted by structures that focus on

heart health issues and where flexibility allowed them to spend significant

periods of time with participants.

Evidence statement R4.10d

Positive staff characteristics included knowledge and interest in heart health

and being upbeat and friendly. A range of specialist staff should be involved.

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Evidence statement R4.11a

Six study reports make specific comments about funding and resource

requirements.

Evidence statement R4 11.b

Five study reports note the need for those with existing roles and

responsibilities to be given resources to take on additional CVD programme

work, or for dedicated positions to be created. Limited time for school-based

staff may be a particular problem.

Evidence statement R4.12a

Two studies identify effective communication between organisations, staff and

the community, to be important, but use different mechanisms to achieve this:

lay health advisers or having a full time project coordinator.

Evidence statement R4.13a

Four study reports discuss recruiting and retaining programme volunteers.

Evidence statement R4.13b

Volunteers need adequate resourcing and leadership, and may be motivated

by witnessing positive changes in the community.

Evidence statement R4.13c

One study suggests that volunteers find health promotion less satisfying than

traditional patient service roles.

Evidence statement R4.13d

Two study reports about the same programme note that lay health advisers,

recruited from the target community, were key.

Evidence statement R4.14a

Two study reports mention the role of GPs in community CVD projects.

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Evidence statement R4.14b

GP uptake was slow and it is suggested that GPs may be less comfortable in

health promotion roles than their traditional role of secondary prevention.

Evidence statement R4.15a

Evidence relating to staff training were identified by six study reports.

Evidence statement R4.15b

While skills training is needed, involvement in the programme itself increases

skills and knowledge through sharing information and implementing

theoretical knowledge.

Evidence statement R4.16a

Five study reports relate to the evaluation of CVD prevention programmes.

Evidence statement R4.16b

Two study reports found that process evaluation and action research raised

self-awareness among staff and promoted programme improvement. While a

third reports that time limited projects limit the possibility of such learning.

Evidence statement R4.16c

Data management was a challenge in long-term projects and those with

multiple strands across a number of organisations.

Evidence statement R4.17a

There is evidence from eight study reports about community engagement in

CVD prevention programmes.

Evidence statement R4.17b

Two study reports suggest that successful community engagement requires

multiple approaches across populations.

Evidence statement R4.17c

Two study reports suggest that successful programmes need to be sensitive

to communities‟ habits and cultural patterns, while a further three describe the

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important of matching programme staff to the social and/or ethnic

characteristics of the target communities.

Evidence statement R4.17d

Challenges to community engagement include engaging community

representatives at strategic levels; building confidence in community leaders;

difficulties breaking into existing networks; competing with other community

events; reaching young people; reluctance due to the legacy of negative

experiences with previous initiatives; lack of enthusiasm in the community.

Evidence statement R4.18a

Seven studies report that the local physical environment had important effects

on the ability of community CVD risk-reduction projects to be successful.

Evidence statement R4.18b

Five studies reported that access to healthy food options was limited, while

unhealthy food was more visible, both in the community and in school-based

programmes.

Evidence statement R4.18c

Local barriers to physical activity including no sidewalks, unmetalled roads or

loose dogs; lack of school provision to secure bikes or store kit which

discourages extra-curricular exercise; and local availability of gyms or other

facilities.

Evidence statement R4.19a

Community and familial norms: There is evidence from one study report

among British Asians that stress from a variety of sources was a noted

problem among both men and women and this might lead to inability to

access essential services or to communicate with professionals.

Evidence statement R4.20a

Attitudes to food and cooking: There is evidence from three study reports that

specific foods and eating patterns may be regarded as important expressions

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of cultural identity. Cultural norms about food types and their preparation may

not be the most healthy from a CVD prevention perspective.

Evidence statement R4.21a

There is evidence from three study reports about cultural attitudes to weight

and exercise.

Evidence statement R4.21b

These suggest that, among some groups, understandings of greater weight as

a sign of wealth and health may persist which may challenge successful

adoption of CVD prevention activities.

Evidence statement R4.21c

Further, specific connotations of language used to describe weight and

physical activities may exist, so shared understandings between clinical and

community meanings should not be assumed.

Evidence statement R4.22a

Fatalism and health: There is evidence from three study reports, among three

different ethnic groups, of fatalistic attitudes where one‟s state of health is the

will of God.

Evidence statement R4.23a

There is evidence from six study reports to suggest that a benefit of

community CVD programmes is in providing leadership that encourages local

attitudes to change for the better.

Evidence statement R4.23b

As well as making personal changes, such „social health‟ encouraged

changes within the family, within the local community and within the wider

social and political community. Despite this, one study suggests that men

remain less likely to use health services.

Evidence statement R4.24a

Nine studies discuss community perceptions of CVD risk factors.

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Evidence statement R4.24b

Six studies report high levels of understanding about CVD risk among the

target population while two suggest limited understanding and two suggest

challenges in turning knowledge into action.

Evidence statement R4.24c

One study suggests that different types of knowledge are at play (theoretical,

practical, experiential and intuitive), and where there is a discrepancy between

theoretical and experiential knowledge, the latter influences what participants

do. These links might be challenged by cues to action (health belief model) –

most significantly breakdown of self-image and social networks.

Evidence statement R4.24d

One study develops a typology of six „ideal types‟ of functional and

dysfunctional attitude among programme participants who see it as a

blessing, an opportunity, a confirmation, a watchman, a disappointment or an

insult. The latter two are negative or „dysfunctional‟ in terms of positive health

choices and more men have these attitudes.

Evidence statement R4.25a

Nine study reports discuss people‟s motivations for, or resistance to, adopting

risk reduction behaviours.

Evidence statement R4.25b

Two studies report that health concerns, sometimes serious, were motivating

factors to participate and two that feedback of physiological test results was

motivating.

Evidence statement R4.25c

Women may be targeted to take heart health practices home, however, two

studies report on difficulties initiating or maintaining family interest and that

resistance from family members was a barrier to adopting healthier behaviour.

It is difficult to maintain behaviour changes amidst the usual business of family

commitments.

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Evidence statement R4.25d

One study suggests that there is a need for ongoing support in order for

behavioural changes to be made and maintained.

Evidence statement R4.25e

One study found that secondary school pupils enjoyed the freedom to make

food choices not available at primary school – pupils‟ food choices, and those

of the wider population, may reflect issues other than health.

Evidence statement R4.26a

Six studies report on participant perceptions of programmes in which they

were involved.

Evidence statement R4.26b

In two studies participants reported improving heart health through weight

loss, increased exercise, as well as increased awareness and use of services

and programme activities. One study also suggests that networks providing

community support was a benefit.

Evidence statement R4.26c

One study found that practical demonstrations were much more successful

than information provision alone.

Evidence statement R4.26d

Two studies suggest that the participants may doubt the credibility of health

messages, with so many sources of, sometimes contradictory, information

available. Matching the characteristics of the community may be important.

Evidence statement R5.2

Community engagement: Positive community engagement requires trusting,

respectful relationships to be built which motivate and support change.

Community engagement should be an ongoing and dynamic partnership

which responds to community needs.

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As CVD may not be seen as an immediate concern within targeted

communities, staff may first need to listen and respond to the existing

concerns of the community. This may be done through participating in existing

networks and forums, or creating forums that have more open agendas, at

least to start with.

Sufficient time is needed to ensure that this is done appropriately and also to

ensure that changes become adopted by the community so that they are

empowered to continue, even if the project itself comes to an end.

Information and education is likely to be more effective if it relates to the

experiences of the community, and if those that deliver it are seen as part of

that community. Appropriately skilled staff are needed for effective community

engagement.

Greater levels of participation, that involve community members as partners or

devolve power to them, may have additional benefits – ensuring that

programmes are truly responsive to community needs, involving local people

in the complexities of planning and delivering such programmes and so

facilitating understanding within the community.

Done well, community engagement may create a positive feedback loop

which motivates change, improving health which produces greater motivation.

However, care needs to be taken to ensure that those adopting behaviour

change are not just those already motivated to change, thereby increasing,

rather than lessening, health inequalities.

Evidence statement R5.3

Staffing – leadership: Strong, inspirational leadership may be important to

initiate, coordinate and drive complex programmes and motivate and

encourage cooperation among multiple staff across a number of agencies with

a range of responsibilities.

To fulfil this, staff are needed whose role is dedicated to the programme and

those with multiple roles need to have appropriate time freed up.

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Leaders may be needed for the project over all, but also for specific elements

of the project, for example, to encourage primary care participation or ensure

local political or funding support. Leaders from within the community are also

needed to champion the project and facilitate engagement.

Expectations of leadership roles should be matched by appropriate control

and responsibility, and given the necessary training and support.

Evidence statement R5.4

Staffing – staff engagement: To ensure that staff are engaged with the aims of

a CVD prevention progamme, they require appropriate training and resources,

a good understanding of how their role fits into the programme overall and a

clear understanding of the extent of their roles and responsibilities.

Evidence statement R5.5

Staffing – GPs: The role of primary care was complicated and sometimes

contradictory. Some GPs may be more comfortable with a secondary, rather

than primary, prevention role, which may explain why some participants found

it difficult to engage them in CVD prevention programmes. Conversely, other

participants viewed primary care as crucial partners in CVD prevention.

Advocacy among other local organisations may be a key role.

Where primary care is involved in CVD prevention programmes, they need to

receive appropriate resources to free-up staff time.

Engaging primary care and keeping them appropriately informed may require

tailored approaches.

Evidence statement R5.6

Staffing – volunteers: Volunteers from within the community may be

particularly effective at informing, motivating and engaging their peers in the

community and enhance community empowerment.

Volunteer workers need to be properly trained and supported to ensure that

they continue to be involved and don‟t get burnt out.

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The issues of paying those involved should be considered carefully.

Evidence statement R5.7

Staffing – multi-agency, multi-disciplinary teams: Public health work to reduce

CVD is likely to require the involvement of multiple agencies and disciplines.

Coordination and cooperation is required to build trust and a sense of shared

purpose through aligning the goals and activities of different agencies

involved, and assigning clear roles and responsibilities to participating

organisations and staff within them. Joint appointments may facilitate this.

Ongoing feedback and communication is vital.

Sufficient time is needed to successfully negotiate and accommodate different

expectations and bureaucracies.

Evidence statement R5.8

Legacy: CVD reduction programmes may enhance their longer-term impact

through ensuring that programme activities are embedded within

organisations and the community.

Appropriate training and support for key staff, and community members, from

project inception may help to ensure activities become „institutionalised‟.

Ongoing sources of funding should also be identified.

Programme impacts should be regularly assessed and results fed back to

staff and organisations so that successful activities are recognised and

adopted. This will require the identification of appropriate resources.

Early and ongoing community engagement may ensure ongoing changes in

healthy behaviours, empowering the community to maintain positive changes.

Short-term projects often fail to leave lasting benefits to a community as their

short-term goal setting may preclude the necessary engagement required.

Evidence statement R5.9

Short time frames: Short time frames for CVD prevention programmes may

threaten success at a number of levels: implementation, staff engagement

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and training, community engagement, evaluation and legacy. It is difficult for

such programmes to meet community needs, staff needs or to permit changes

to become embedded in the community. This may lead communities and local

agencies to lose faith in such interventions, further hampering the ability of

future work to be successful in those areas.

Evidence statement R5.10

Structural barriers: At a macro-level, changes in the broader political

environment can have dramatic effects on the adoption and continuation of

prevention activities.

Support for CVD prevention programmes may be affected by changing

political priorities around prevention and treatment of illness.

Evidence statement R5.11

Piloting and monitoring: Cyclical approaches to monitoring and evaluation,

such as piloting, process evaluation and action research, allow project to be

responsive to local needs, adapting or removing inappropriate projects and

allowing successful projects to be rolled out.

Information from this process fed back to staff in a timely way can help

develop a sense of ownership and cooperation and motivate good practice.

Organisations and individuals should also learn from the experiences of

previous projects.

Evidence statement R5.12

Challenges of evaluation: Commissioners and funders may need to allow

flexibility in programme evaluation designs to allow them to adapt to local

needs, rather than requiring fixed plans prior to funding. In addition,

programmes and evaluations should allow sufficient time for outcomes to be

achieved.

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Multiple methods may be needed to evaluate important aspects of CVD

prevention programmes, such as community empowerment, that are not all

easily captured through numerical outcome data.

Programmes that measure only population-level changes may not capture

large impacts for some individuals, and this may be important, especially

where health inequalities are addressed.

Evidence statement CE1

Three studies gave results in cost per life-year gained for population-based

programmes compared to no intervention. The results ranged from cost-

saving to £240,000 per life-year gained.

Evidence statement CE2

Two studies gave results in cost per QALY or DALY (disability-adjusted life

years) for population-based programmes compared to no intervention. Results

ranged from £10 per QALY to £96 per DALY.

Evidence statement CE3

Two studies gave results in cost per case prevented for population-based

programmes compared to no intervention. Results ranged from cost saving to

£22,000 per case prevented.

Evidence statement CE4

Five studies reported results in cost per life-year gained for some form of

screening strategy compared to no intervention. Results ranged from cost

saving to £140,000 per life-year gained.

Evidence statement CE5

Two studies gave results in cost per case prevented for screening compared

to no intervention. Results ranged from £10,000 to £730,000 per case

prevented.

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Evidence statement CE6

Two studies gave results per 1% reduction in coronary risk for screening

compared to no intervention. Results ranged from £2.25 to £5.30 per 1%

reduction for one person.

Evidence statement CE7

One study gave a result of £0.80 per pound weight lost for a screening

programme compared to no intervention.

Evidence statement CE8

One study gave results ranging from £12,000 to £120,000 per life-year gained

and £100,000 to £230,000 per QALY for screening compared to a population-

based approach.

Evidence statement CE9

One study gave results from cost saving to £39,000 per life-year gained for

some form of exercise training.

Additional evidence

Expert reports:

ER 1: „The effectiveness of physical activity promotion

interventions‟

ER 2: „Health policy analysis‟

ER 3: „Expert testimony on salt and cardiovascular disease‟

ER 4: „The relationship between commercial interests and risk

of cardiovascular disease‟

ER 5: „Regional development of a population-based

collaborative CVD prevention strategy: the experience of NHS

West Midlands‟

ER 6: „NICE guidance on the prevention of CVD at population

level: evidence from the Co-operative Group‟

ER 7: „Population and community programmes addressing

multiple risk factors to prevent cardiovascular disease (CVD):

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addendum to qualitative study produced by Peninsula

Technology Assessment Group for NICE: CVD programme –

Heart of Mersey (HoM)‟

ER 8: „Expert testimony paper on the independent evaluation

of ‟have a heart Paisley‟ phase one (Scotland‟s national CHD

prevention demonstration project)‟

ER 9: „Expert testimony on the public health harm caused by

industrially produced trans fatty acids and actions to reduce

and eliminate them from the food system in the UK‟

ER 10: „Prevention of cardiovascular disease at a population

level: evidence on interventions to address dietary fats‟

ER 11: „CVD risk factors: paradigms and pathways‟

ER 12: „CVD prevention in populations: lessons from other

countries‟

ER 13: „Will CVD prevention widen health inequalities?‟

Report 14: „Food manufacturer‟s perspective‟

Cost-effectiveness evidence

The economic analysis consisted of a review of economic evaluations and a

cost-effectiveness analysis.

„Prevention of cardiovascular disease at population level (Question 1; cost-

effectiveness)‟

„Prevention of cardiovascular disease at population level: modelling

strategies for primary prevention of cardiovascular disease‟.

Some primary prevention programmes involving education, mass media and

screening with a general population were found to be effective and cost

effective. They may reduce some of the risk factors for CVD, including

changing behaviours which increase the risk. However, when the findings

from all programmes were summarised, the overall effect on health outcomes

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was uncertain. In addition, as these programmes were conducted many years

ago, the findings may not be generally applicable in the UK now.

The cost-effectiveness analysis strongly suggests that legislation likely to

reduce the risk of CVD can be expected to produce a net cost saving to the

public sector – as well as improving health. (Unless a very large sum of

money needs to be spent on implementation.)

For example, implementing a CVD prevention programme based on the North

Karelia project would result in an incremental cost-effectiveness ratio of

approximately £7000 per quality-adjusted life year (QALY). For the Stanford

Five City Project, the total healthcare cost savings almost equal the estimated

cost of the project. The benefits of reducing the prevalence of smoking would

also make the programme cost saving.

At the request of the Programme Development Group (PDG), the scope of the

modelling was extended beyond programmes for which there was direct

evidence of effectiveness. Interventions modelled included:

The North Karelia project – including the effect of a net percentage

reduction in serum cholesterol of 3% for men and 1% for women, and a

reduction in systolic blood pressure of 3% for men and 5% for women.

The Stanford Five City Project – the effect of a 4% reduction in systolic

blood pressure and a 2% decrease in serum cholesterol among the general

population.

Legislation to ban trans fats and so reduce trans fatty acid (TFA) levels in

the population so that it only accounts for approximately 0.7% of total fat

consumed.

Legislation to reduce the population‟s salt intake by 3g and 6g per day.

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Appendix D Gaps in the evidence

The PDG identified a number of gaps in the evidence related to the

programmes under examination based on an assessment of the evidence.

These gaps are set out below.

1. There is a lack of UK studies on the effectiveness of programmes to

prevent CVD among black and minority ethnic groups living in the UK.

2. There is a lack of evidence on the effectiveness of interventions

targeting those with high risk factors who believe their health is bad.

3. There is a lack of evidence on the effectiveness of providing emotional

support and help to develop general coping skills as part of

interventions to prevent CVD.

4. There is a lack of evidence on the effectiveness of CVD prevention

programmes involving the families of those at risk.

5. There is a lack of controlled comparison studies looking at the

effectiveness of lay health advisers in helping to prevent CVD.

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Appendix E: supporting documents

Supporting documents are available at

www.nice.org.uk/guidance/PHG/Wave17/26 These include the following.

Evidence reviews:

Review 1: „Prevention of cardiovascular disease at population

level (Question 1; phase 1)‟

Review 2: „Prevention of cardiovascular disease at population

level (Question 1; phase 2)‟

Review 3: „Prevention of cardiovascular disease at population

level (Question 1; phase 3)‟

Review 4: „Barriers to, and facilitators for, multiple risk factor

programmes aimed at reducing cardiovascular disease within

a given population: a systematic review of qualitative

research‟.

Primary research:

Review 5: ‟Population and community programmes

addressing multiple risk factors to prevent cardiovascular

disease: A qualitative study into how and why some

programmes are more successful than others‟.

Economic analysis:

Review 6: „Prevention of cardiovascular disease at population

level (Question 1; cost-effectiveness)‟

„Prevention of cardiovascular disease at population level:

modelling strategies for primary prevention of cardiovascular

disease‟.

Expert reports:

Report 1: „The effectiveness of physical activity promotion

interventions‟

Report 2: „Health policy analysis‟

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Report 3: „Expert testimony on salt and cardiovascular

disease‟

Report 4: „The relationship between commercial interests and

risk of cardiovascular disease‟

Report 5: „Regional development of a population-based

collaborative CVD prevention strategy: the experience of NHS

West Midlands‟

Report 6: „NICE guidance on the prevention of CVD at

population level: evidence from the Co-operative Group‟

Report 7: „Population and community programmes addressing

multiple risk factors to prevent cardiovascular disease (CVD):

addendum to qualitative study produced by Peninsula

Technology Assessment Group for NICE: CVD programme –

Heart of Mersey (HoM)‟

Report 8: „Expert testimony paper on the independent

evaluation of “have a heart Paisley” phase one (Scotland‟s

national CHD prevention demonstration project)‟

Report 9: „Expert testimony on the public health harm caused

by industrially produced trans fatty acids and actions to

reduce and eliminate them from the food system in the UK‟

Report 10: „Prevention of cardiovascular disease at a

population level: evidence on interventions to address dietary

fats‟

Report 11: „CVD risk factors: paradigms and pathways‟

Report 12: „CVD prevention in populations: lessons from other

countries‟

Report 13: „Will CVD prevention widen health inequalities?‟

Report 14: „Food manufacturer‟s perspective‟.

For information on how NICE public health guidance is developed see:

„Methods for development of NICE public health guidance (second edition,

2009)‟ available from www.nice.org.uk/phmethods

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„The NICE public health guidance development process: An overview for

stakeholders including public health practitioners, policy makers and the

public (second edition, 2009)‟ available from www.nice.org.uk/phprocess